{"success":true,"result":{"resource_id":"d_8cfe111e0a5a5cf5b598e78851e58ad4","fields":[{"type":"text","id":"device_name"},{"type":"text","id":"description"},{"type":"text","id":"gmdn_term"},{"type":"text","id":"medical_speciality_area"},{"type":"text","id":"hs_code"},{"type":"text","id":"hsa_product_code"},{"type":"text","id":"medical_device_class"},{"type":"text","id":"device_registration_number"},{"type":"text","id":"registration_date"},{"type":"text","id":"change_notification_approval_date"},{"type":"text","id":"retention_due_date"},{"type":"text","id":"product_owner_name"},{"type":"text","id":"product_owner_short_name"},{"type":"text","id":"product_owner_address"},{"type":"text","id":"registrant_name"},{"type":"text","id":"registrant_address"},{"type":"text","id":"importer_name"},{"type":"text","id":"importer_address"},{"type":"text","id":"model_name"},{"type":"text","id":"model_identifier"},{"type":"int4","id":"_id"}],"records":[{"_id":1,"device_name":"TRUABUTMENT AOT Straight Abutment","description":"AOT STRAIGHT Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.","gmdn_term":"Dental implant suprastructure, permanent, preformed","medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251030A0008","registration_date":"30/10/2025 19:23","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"TruAbutment Korea Co., Ltd.","product_owner_short_name":"TruAbutment Korea Co., Ltd.","product_owner_address":"104-214 to 216, 101-1308 to 1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14449, Korea, South","registrant_name":"ANDAMAN MEDICAL PTE. LTD.","registrant_address":", 300 TAMPINES AVENUE 5, #09-02, NTUC INCOME TAMPINES JUNCTION, Singapore 529653","importer_name":null,"importer_address":null,"model_name":"AOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Base\nAOT Base\nAOT Base\nAOT Base\nAOT Base\nAOT Base\nAOT Base\nAOT Base\nAOT Temporary\nAOT Temporary\nAOT Temporary\nAOT Temporary\nAOT Base Screw\nAOT Base Screw\nAOT Base Screw\nAOT Base Screw\nAOT Base Screw\nAOT Base Screw\nAOT Base Screw\nAOT Base Screw\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight\nAOT Straight","model_identifier":"AE30-ATS1\nAE30-ATS2\nAE30-ATS3\nAE36-ATS1\nAE36-ATS2\nAE36-ATS3\nAE42-ATS1\nAE42-ATS2\nAE42-ATS3\nAE48-ATS1\nAE48-ATS2\nAE48-ATS3\nAE54-ATS1\nAE54-ATS2\nAE54-ATS3\nAOT-BSLH\nAOT-BSLH12\nAOT-BSLT\nAOT-BSLU\nAOT-BSSH\nAOT-BSSH12\nAOT-BSST\nAOT-BSSU\nCMM-ATTAH\nCMM-ATTAH12\nCMM-ATTAT\nCMM-ATTAU\nCMM-ATWH\nCMM-ATWH(5)\nCMM-ATWH12\nCMM-ATWH12(5)\nCMM-ATWT\nCMM-ATWT(5)\nCMM-ATWU\nCMM-ATWU(5)\nDSU-ATS1\nDSU-ATS2\nDSU-ATS3\nIDL30-ATS1\nIDL30-ATS2\nIDL30-ATS3\nMRD-ATS1\nMRD-ATS2\nMRD-ATS3\nNA3-ATS1\nNA3-ATS2\nNA3-ATS3\nNAN-ATS1\nNAN-ATS2\nNAN-ATS3\nNAR-ATS1\nNAR-ATS2\nNAR-ATS3\nNAW-ATS1\nNAW-ATS2\nNAW-ATS3\nNDG-ATS1\nNDG-ATS2\nNDG-ATS3\nOTM-ATS1\nOTM-ATS2\nOTM-ATS3\nOTR-ATS1\nOTR-ATS2\nOTR-ATS3\nSBN-ATS1\nSBN-ATS2\nSBN-ATS3\nSBR-ATS1\nSBR-ATS2\nSBR-ATS3\nSBS-ATS1\nSBS-ATS2\nSBS-ATS3\nSXR-ATS1\nSXR-ATS2\nSXR-ATS3\nZV3-ATS1\nZV3-ATS2\nZV3-ATS3\nZV4-ATS1\nZV4-ATS2\nZV4-ATS3\nZV5-ATS1\nZV5-ATS2\nZV5-ATS3\nZVN-ATS1\nZVN-ATS2\nZVN-ATS3"},{"_id":2,"device_name":"TRUABUTMENT T-L Straight Abutment","description":"T-L STRAIGHT Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.","gmdn_term":"Dental implant suprastructure, permanent, preformed","medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251030Z0007","registration_date":"30/10/2025 19:22","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"TruAbutment Korea Co., Ltd.","product_owner_short_name":"TruAbutment Korea Co., Ltd.","product_owner_address":"104-214 to 216, 101-1308 to 1309, 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14449, Korea, South","registrant_name":"ANDAMAN MEDICAL PTE. LTD.","registrant_address":", 300 TAMPINES AVENUE 5, #09-02, NTUC INCOME TAMPINES JUNCTION, Singapore 529653","importer_name":null,"importer_address":null,"model_name":"T-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight\nT-L Straight","model_identifier":"AE30-TLS1\nAE30-TLS2\nAE30-TLS3\nAE30-TLS4\nAE30-TLS5\nAE30-TLS6\nAE36-TLS1\nAE36-TLS2\nAE36-TLS3\nAE36-TLS4\nAE36-TLS5\nAE36-TLS6\nAE42-TLS1\nAE42-TLS2\nAE42-TLS3\nAE42-TLS4\nAE42-TLS5\nAE42-TLS6\nAE48-TLS1\nAE48-TLS2\nAE48-TLS3\nAE48-TLS4\nAE48-TLS5\nAE48-TLS6\nAE54-TLS1\nAE54-TLS2\nAE54-TLS3\nAE54-TLS4\nAE54-TLS5\nAE54-TLS6\nDSU-TLS1\nDSU-TLS2\nDSU-TLS3\nDSU-TLS4\nDSU-TLS5\nDSU-TLS6\nIDL30-TLS1\nIDL30-TLS2\nIDL30-TLS3\nIDL30-TLS4\nIDL30-TLS5\nIDL30-TLS6\nMRD-TLS1\nMRD-TLS2\nMRD-TLS3\nMRD-TLS4\nMRD-TLS5\nMRD-TLS6\nNA3-TLS1\nNA3-TLS2\nNA3-TLS3\nNA3-TLS4\nNA3-TLS5\nNA3-TLS6\nNAN-TLS1\nNAN-TLS2\nNAN-TLS3\nNAN-TLS4\nNAN-TLS5\nNAN-TLS6\nNAR-TLS1\nNAR-TLS2\nNAR-TLS3\nNAR-TLS4\nNAR-TLS5\nNAR-TLS6\nNAW-TLS1\nNAW-TLS2\nNAW-TLS3\nNAW-TLS4\nNAW-TLS5\nNAW-TLS6\nNDG-TLS1\nNDG-TLS2\nNDG-TLS3\nNDG-TLS4\nNDG-TLS5\nNDG-TLS6\nOTM-TLS1\nOTM-TLS2\nOTM-TLS3\nOTM-TLS4\nOTM-TLS5\nOTM-TLS6\nOTR-TLS1\nOTR-TLS2\nOTR-TLS3\nOTR-TLS4\nOTR-TLS5\nOTR-TLS6\nSBN-TLS1\nSBN-TLS2\nSBN-TLS3\nSBN-TLS4\nSBN-TLS5\nSBN-TLS6\nSBR-TLS1\nSBR-TLS2\nSBR-TLS3\nSBR-TLS4\nSBR-TLS5\nSBR-TLS6\nSBS-TLS1\nSBS-TLS2\nSBS-TLS3\nSBS-TLS4\nSBS-TLS5\nSBS-TLS6\nSXR-TLS1\nSXR-TLS2\nSXR-TLS3\nSXR-TLS4\nSXR-TLS5\nSXR-TLS6\nZV3-TLS1\nZV3-TLS2\nZV3-TLS3\nZV3-TLS4\nZV3-TLS5\nZV3-TLS6\nZV4-TLS1\nZV4-TLS2\nZV4-TLS3\nZV4-TLS4\nZV4-TLS5\nZV4-TLS6\nZV5-TLS1\nZV5-TLS2\nZV5-TLS3\nZV5-TLS4\nZV5-TLS5\nZV5-TLS6\nZVN-TLS1\nZVN-TLS2\nZVN-TLS3\nZVN-TLS4\nZVN-TLS5\nZVN-TLS6"},{"_id":3,"device_name":"Ziehm Imaging Ziehm Vision FD","description":"The system is a mobile C-arm providing image data by means of a non-invasive\nx-ray technique during medical procedures and stores them temporarily. The system is intended for use specifically but not limited to the imaging of soft tissues. The system’s intended use is therefore the same as the predecessor device named Ziehm Vision FD.\nThe system is intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients. The system is intended for use with human bodies covering structures such as but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication.","gmdn_term":"Mobile general-purpose fluoroscopic x-ray system, digital","medical_speciality_area":"Radiology / Imaging","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251030Y0006","registration_date":"30/10/2025 19:19","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"Ziehm Imaging GmbH","product_owner_short_name":"Ziehm Imaging GmbH","product_owner_address":"Lina-Ammon-Strasse 10, 90471 Nuremberg, Germany","registrant_name":"ZIEHM IMAGING SINGAPORE PTE. LTD.","registrant_address":"23, SERANGOON NORTH AVENUE 5, #05-04, BTC CENTRE, Singapore 554530","importer_name":"ZIEHM IMAGING SINGAPORE PTE. LTD.","importer_address":"23, SERANGOON NORTH AVENUE 5, #05-04, BTC CENTRE, Singapore 554530","model_name":"Ziehm Vision FD\nZiehm Vision FD","model_identifier":"Mobile Stand\nMobile Stand"},{"_id":4,"device_name":"Savio Industrial Syaloset Hyaluronic Acid Sodium Salt Solution ","description":"Syaloset Plus and Syaloset 2000 is a temporary substitute of synovial fluid and it is indicated for treating the decreased mobility and pain of patients with degenerative or traumatic joint disease of the synovial articulations of hips and knees, without active synovitis. The product acts by providing lubrication and mechanical support. It is especially suitable for treating the symptoms of Osteoarthritis.","gmdn_term":"Synovial fluid supplementation medium","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251030X0005","registration_date":"30/10/2025 19:18","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"Savio Industrial S.R.L.","product_owner_short_name":"Savio Industrial S.R.L.","product_owner_address":"Via E. Bazzano, 14,, 16019 Ronco Scrivia (GE),, Italy","registrant_name":"RIVER PHARMA ASIA PACIFIC PTE. LTD.","registrant_address":"17, PHILLIP STREET, #05-01, GRAND BUILDING, Singapore 048695","importer_name":"MLS LOGISTIC SERVICES PTE. LTD.","importer_address":"5, TAI SENG DRIVE, #02-01, SCA CREATIVE CENTRE, Singapore 535217","model_name":"Syaloset 2000\nSyaloset Plus","model_identifier":"970978211\n971744646"},{"_id":5,"device_name":"Audicon Ceretone Hearing Aids (BTE, Wireless, Digital)","description":"The hearing aid is intended to compensate of impaired hearing.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251030W0004","registration_date":"30/10/2025 15:43","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"Audicon Corporation","product_owner_short_name":"Audicon Corporation","product_owner_address":"3602 Inland Empire Blvd. #A200, Ontario, CA 91764, United States","registrant_name":"ENTRUST EAR, NOSE, THROAT, HEAD AND NECK SURGERY CENTER PTE. LTD.","registrant_address":"437, TANJONG KATONG ROAD, #16-04, KING'S MANSION, Singapore 437147","importer_name":null,"importer_address":null,"model_name":"Beacon","model_identifier":"JH-DW5"},{"_id":6,"device_name":"Audicon Ceretone Hearing Aids (BTE, Digital) ","description":"The hearing aid is intended to compensate of impaired hearing.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251030V0003","registration_date":"30/10/2025 14:38","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"Audicon Corporation","product_owner_short_name":"Audicon Corporation","product_owner_address":"3602 Inland Empire Blvd. #A200, Ontario, CA 91764, United States","registrant_name":"ENTRUST EAR, NOSE, THROAT, HEAD AND NECK SURGERY CENTER PTE. LTD.","registrant_address":"437, TANJONG KATONG ROAD, #16-04, KING'S MANSION, Singapore 437147","importer_name":null,"importer_address":null,"model_name":"Ceretone Hearing Aids - SOLID\nCeretone Hearing Aids - NEXUS","model_identifier":"JH-D12\nJH-D36"},{"_id":7,"device_name":"SHOFU CADCAM CERAMIC BASED RESTORATIVE","description":"SHOFU BLOCK HC and SHOFU DISK HC are intended for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations and implant supported restorations, using a dental CAD /CAM system.","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251030U0002","registration_date":"30/10/2025 10:00","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"Shofu Inc.","product_owner_short_name":"Shofu Inc.","product_owner_address":"11 KAMITAKAMATSU-CHO, FUKUINE HIGASHIYAMA-KU, KYOTO 605-0983, Japan","registrant_name":"SHOFU DENTAL ASIA-PACIFIC PTE. LTD.","registrant_address":"1, SCIENCE PARK ROAD, #01-01, THE CAPRICORN, Singapore 117528","importer_name":null,"importer_address":null,"model_name":"SHOFU BLOCK HC INTRO SET for CEREC\nSHOFU BLOCK HC INTRO SET\nSHOFU BLOCK HC for CEREC W2-LT S 5PCS\nSHOFU BLOCK HC S W2-LT (5PCS)\nSHOFU BLOCK HC for CEREC A1-HT S 5PCS\nSHOFU BLOCK HC S A1-HT (5PCS)\nSHOFU BLOCK HC for CEREC A1-LT S 5PCS\nSHOFU BLOCK HC S A1-LT (5PCS)\nSHOFU BLOCK HC for CEREC A2-HT S 5PCS\nSHOFU BLOCK HC S A2-HT (5PCS)\nSHOFU BLOCK HC for CEREC A2-LT S 5PCS\nSHOFU BLOCK HC S A2-LT (5PCS)\nSHOFU BLOCK HC for CEREC A3.5-LT S 5PCS\nSHOFU BLOCK HC S A3.5-LT (5PCS)\nSHOFU BLOCK HC for Ceramill W2-LT M 5PCS\nSHOFU BLOCK HC for CEREC W2-LT M 5PCS\nSHOFU BLOCK HC M W2-LT (5PCS)\nSHOFU BLOCK HC for Ceramill A1-HT M 5PCS\nSHOFU BLOCK HC for CEREC A1-HT M 5PCS\nSHOFU BLOCK HC M A1-HT (5PCS)\nSHOFU BLOCK HC for Ceramill A1-LT M 5PCS\nSHOFU BLOCK HC for CEREC A1-LT M 5PCS\nSHOFU BLOCK HC M A1- LT (5PCS)\nSHOFU BLOCK HC for Ceramill A2-HT M 5PCS\nSHOFU BLOCK HC for CEREC A2-HT M 5PCS\nSHOFU BLOCK HC M A2-HT (5PCS)\nSHOFU BLOCK HC for Ceramill A2-LT M 5PCS\nSHOFU BLOCK HC for CEREC A2-LT M 5PCS\nSHOFU BLOCK HC M A2-LT (5PCS)\nSHOFU BLOCK HC for Ceramill A3.5-LT M 5PCS\nSHOFU BLOCK HC for CEREC A3.5-LT M 5PCS\nSHOFU BLOCK HC M A3.5-LT (5PCS)\nSHOFU BLOCK HC for CEREC A3-HT S 5PCS\nSHOFU BLOCK HC S A3-HT (5PCS)\nSHOFU BLOCK HC for CEREC A3-LT S 5PCS\nSHOFU BLOCK HC S A3-LT (5PCS)\nSHOFU BLOCK HC for CEREC B3-LT S 5PCS\nSHOFU BLOCK HC S B3-LT (5PCS)\nSHOFU BLOCK HC for CEREC 59 S 5PCS\nSHOFU BLOCK HC S 59 (5PCS)\nSHOFU BLOCK HC for CEREC OC S 5PCS\nSHOFU BLOCK HC S OC (5PCS)\nSHOFU BLOCK HC for Ceramill A3-HT M 5PCS\nSHOFU BLOCK HC for CEREC A3-HT M 5PCS\nSHOFU BLOCK HC M A3-HT (5PCS)\nSHOFU BLOCK HC for Ceramill A3-LT M 5PCS\nSHOFU BLOCK HC for CEREC A3-LT M 5PCS\nSHOFU BLOCK HC M A3-LT (5PCS)\nSHOFU BLOCK HC for Ceramill B3-LT M 5PCS\nSHOFU BLOCK HC for CEREC B3-LT M 5PCS\nSHOFU BLOCK HC M B3-LT (5PCS)\nSHOFU BLOCK HC for Ceramill 59 M 5PCS\nSHOFU BLOCK HC for CEREC 59 M 5PCS\nSHOFU BLOCK HC M 59 (5PCS)\nSHOFU BLOCK HC for Ceramill OC M 5PCS\nSHOFU BLOCK HC for CEREC OC M 5PCS\nSHOFU BLOCK HC M OC (5PCS)\nSHOFU DISK HC W2-LT T14-S 1disk\nSHOFU DISK HC A1-LT T14-S 1disk\nSHOFU DISK HC A2-LT T14-S 1disk\nSHOFU DISK HC A3-LT T14-S 1disk\nSHOFU DISK HC A3.5-LT T14-S 1disk\nSHOFU DISK HC B3-LT T14-S 1disk\nSHOFU DISK HC A1-HT T14-S 1disk\nSHOFU DISK HC A2-HT T14-S 1disk\nSHOFU DISK HC A3-HT T14-S 1disk\nSHOFU DISK HC 59 T14-S 1disk\nSHOFU DISK HC OC T14-S 1disk\nSHOFU BLOCK HC A2-2L M 5PCS\nSHOFU BLOCK HC A3-2L M 5PCS\nSHOFU BLOCK HC A3.5-2L M 5PCS\nSHOFU BLOCK HC A2-2L S 5PCS\nSHOFU BLOCK HC A3-2L S 5PCS\nSHOFU BLOCK HC A3.5-2L S 5PCS\nSHOFU BLOCK HC for CEREC A2-2L M 5PCS\nSHOFU BLOCK HC for CEREC A3-2L M 5PCS\nSHOFU BLOCK HC for CEREC A3.5-2L M 5PCS\nSHOFU BLOCK HC for CEREC A2-2L S 5PCS\nSHOFU BLOCK HC for CEREC A3-2L S 5PCS\nSHOFU BLOCK HC for CEREC A3.5-2L S 5PCS\nSHOFU BLOCK HC for Ceramill A2-2L M 5PCS\nSHOFU BLOCK HC for Ceramill A3-2L M 5PCS\nSHOFU BLOCK HC for Ceramill A3.5-2L M 5PCS","model_identifier":"2150C\n2150U\n2151C\n2151U\n2152C\n2152U\n2153C\n2153U\n2154C\n2154U\n2155C\n2155U\n2156C\n2156U\n2157A\n2157C\n2157U\n2158A\n2158C\n2158U\n2159A\n2159C\n2159U\n2160A\n2160C\n2160U\n2161A\n2161C\n2161U\n2162A\n2162C\n2162U\n2163C\n2163U\n2164C\n2164U\n2165C\n2165U\n2166C\n2166U\n2167C\n2167U\n2168A\n2168C\n2168U\n2169A\n2169C\n2169U\n2170A\n2170C\n2170U\n2171A\n2171C\n2171U\n2172A\n2172C\n2172U\n2180S\n2181S\n2182S\n2183S\n2184S\n2185S\n2186S\n2187S\n2188S\n2189S\n2190S\nZ0001\nZ0002\nZ0003\nZ0005\nZ0006\nZ0007\nZ0008\nZ0009\nZ0010\nZ0011\nZ0012\nZ0013\nZ0014\nZ0015\nZ0016"},{"_id":8,"device_name":"Siemens SOMATOM Pro.Pulse","description":"Computed tomography system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.\nThe images delivered by the system can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations.","gmdn_term":"Cone beam computed tomography system, head/neck","medical_speciality_area":"Radiology / Imaging","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251030T0001","registration_date":"30/10/2025 7:55","change_notification_approval_date":null,"retention_due_date":"29/10/2026 0:00","product_owner_name":"Siemens Healthcare GmbH","product_owner_short_name":"Siemens Healthcare GmbH","product_owner_address":"Henkestr. 127, 91052 Erlangen, Germany","registrant_name":"SIEMENS HEALTHCARE PTE. LTD.","registrant_address":"60, MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615","importer_name":"SIEMENS HEALTHCARE PTE. LTD.","importer_address":"60, MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615","model_name":"SOMATOM Pro.Pulse","model_identifier":"11594780"},{"_id":9,"device_name":"Beckman Coulter Access HBsAg ","description":"The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection\nof hepatitis B virus surface antigen (HBsAg) in human serum and plasma using the DxI 9000 Access Immunoassay\nAnalyzer.\nThe Access HBsAg assay is intended to be used as an aid in the diagnosis of hepatitis B virus (HBV) infection, and as a\nscreening test for blood and plasma donors. The assay is not intended for the testing or screening of pooled specimens.\nThe Access HBsAg assay is for use on the DxI 9000 Access Immunoassay Analyzer only.","gmdn_term":"Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay","medical_speciality_area":"Immunology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251029E0004","registration_date":"29/10/2025 16:01","change_notification_approval_date":null,"retention_due_date":"28/10/2026 0:00","product_owner_name":"Beckman Coulter Inc","product_owner_short_name":"Beckman Coulter Inc","product_owner_address":"250 S. Kraemer Blvd, Brea California USA 92821, United States","registrant_name":"BECKMAN COULTER SINGAPORE PTE. LTD.","registrant_address":"70, BENDEMEER ROAD, #03-04, LUZERNE, Singapore 339940","importer_name":"BECKMAN COULTER SINGAPORE PTE. LTD.","importer_address":"70, BENDEMEER ROAD, #03-04, LUZERNE, Singapore 339940","model_name":"Access HBsAg\nAccess HBsAg Calibrator\nAccess HBsAg QC","model_identifier":"C39422\nC39423\nC39424"},{"_id":10,"device_name":"Medtronic SynchroMed™ III Programmable pump","description":"The implantable programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site.","gmdn_term":"Implantable intrathecal infusion pump, programmable","medical_speciality_area":"Neurology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251029D0003","registration_date":"29/10/2025 15:56","change_notification_approval_date":null,"retention_due_date":"28/10/2026 0:00","product_owner_name":"Medtronic Inc","product_owner_short_name":"Medtronic Inc","product_owner_address":"710 Medtronic Parkway, Minneapolis, MN 55432, United States","registrant_name":"MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)","registrant_address":"50, PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384","importer_name":"MEDTRONIC INTERNATIONAL TRADING PTE. LTD.; MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)","importer_address":"50, PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384","model_name":"Synchromed™ III\nSynchromed™ III\nSynchroMed™ Clinician Programmer Application\nHandset with Communicator","model_identifier":"8667-20\n8667-40\nA810\nTH90T02"},{"_id":11,"device_name":"Pulse Wave A-fib Prompt App","description":"The Pulse Wave A-fib Prompt App is an independent app that works with Huawei wearable devices. It analyzes pulse data to identify irregular heart rhythms and notifies users of suspected atrial fibrillation (A-fib). Users can actively collect data or enable automatic data collection in the background. When users choose to enable automatic data collection in the background, the app does not send a notification every time it detects suspected A-fib, so no notification does not mean that there is no irregularity. This data is only collected when the user is still. The app can be used to supplement the decision for A-fib screening. The app is not intended to diagnosis of atrial fibrillation. The app should not be used by anyone under the age of 18.\n","gmdn_term":null,"medical_speciality_area":"Cardiovascular","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251029C0002","registration_date":"29/10/2025 15:40","change_notification_approval_date":null,"retention_due_date":"28/10/2026 0:00","product_owner_name":"Huawei Device Co., Ltd","product_owner_short_name":"Huawei Device Co., Ltd","product_owner_address":"No.5 , Alishan Road, Hi-Tech industrial development Zone, Songshan lake, Dong Guan, Guangdong, P.R. China, China","registrant_name":"HUAWEI INTERNATIONAL PTE. LTD.","registrant_address":"51, CHANGI BUSINESS PARK CENTRAL 2, #07-08, THE SIGNATURE, Singapore 486066","importer_name":"HUAWEI INTERNATIONAL PTE. LTD.","importer_address":"51, CHANGI BUSINESS PARK CENTRAL 2, #07-08, THE SIGNATURE, Singapore 486066","model_name":"Pulse Wave A-fib Prompt App","model_identifier":"PPG-1"},{"_id":12,"device_name":"Cambridge Interventional CRF Radiofrequency Ablation System","description":"The CRF Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.","gmdn_term":"Percutaneous radio-frequency ablation system generator","medical_speciality_area":"General & Plastic Surgery","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251029B0001","registration_date":"29/10/2025 12:19","change_notification_approval_date":null,"retention_due_date":"28/10/2026 0:00","product_owner_name":"Cambridge Interventional LLC","product_owner_short_name":"Cambridge Interventional LLC","product_owner_address":"78 Cambridge Street, Burlington, MA 01803, United States","registrant_name":"KROMAX SOUTH ASIA PTE. LTD.","registrant_address":"26, SIN MING LANE, #07-118, MIDVIEW CITY, Singapore 573971","importer_name":"KROMAX SOUTH ASIA PTE. LTD.","importer_address":"26, SIN MING LANE, #07-118, MIDVIEW CITY, Singapore 573971","model_name":"CRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nCannulaCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nCRF-Pump\nTemperature Probe Kit\nTemperature Probe Kit\nTempNeedleCRF\nTempNeedleCRF\nTempProbeCRF\nTempProbeCRF\nTubingCRF\nTubingCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF\nElectrodeCRF","model_identifier":"CRF\nCRF-C1010\nCRF-C1010-B\nCRF-C1020\nCRF-C1020-B\nCRF-C1025\nCRF-C1025-B\nCRF-C1030\nCRF-C1030-B\nCRF-C1040\nCRF-C1040-B\nCRF-C1050\nCRF-C1050-B\nCRF-C1510\nCRF-C1510-B\nCRF-C1520\nCRF-C1520-B\nCRF-C1525\nCRF-C1525-B\nCRF-C1530\nCRF-C1530-B\nCRF-C1535\nCRF-C1535-B\nCRF-C1540\nCRF-C1540-B\nCRF-C1545\nCRF-C1545-B\nCRF-C1550\nCRF-C1550-B\nCRF-C2010\nCRF-C2010-B\nCRF-C2020\nCRF-C2020-B\nCRF-C2025\nCRF-C2025-B\nCRF-C2030\nCRF-C2030-B\nCRF-C2035\nCRF-C2035-B\nCRF-C2040\nCRF-C2040-B\nCRF-C2045\nCRF-C2045-B\nCRF-C2050\nCRF-C2050-B\nCRF-C2510\nCRF-C2510-B\nCRF-C2520\nCRF-C2520-B\nCRF-C2525\nCRF-C2525-B\nCRF-C2530\nCRF-C2530-B\nCRF-C2535\nCRF-C2535-B\nCRF-C2540\nCRF-C2540-B\nCRF-C2545\nCRF-C2545-B\nCRF-C2550\nCRF-C2550-B\nCRF-E10\nCRF-E10-B\nCRF-E15\nCRF-E15-B\nCRF-E20\nCRF-E20-B\nCRF-E25\nCRF-E25-B\nCRF-N1005\nCRF-N1005-B\nCRF-N1010\nCRF-N1010-B\nCRF-N1015\nCRF-N1015-B\nCRF-N1020\nCRF-N1020-B\nCRF-N1505\nCRF-N1505-B\nCRF-N1510\nCRF-N1510-B\nCRF-N1515\nCRF-N1515-B\nCRF-N1520\nCRF-N1520-B\nCRF-N2005\nCRF-N2005-B\nCRF-N2010\nCRF-N2010-B\nCRF-N2015\nCRF-N2015-B\nCRF-N2020\nCRF-N2020-B\nCRF-N2505\nCRF-N2505-B\nCRF-N2510\nCRF-N2510-B\nCRF-N2515\nCRF-N2515-B\nCRF-N2520\nCRF-N2520-B\nCRF-Pump\nCRF-T\nCRF-T-B\nCRF-TN\nCRF-TN-B\nCRF-TP\nCRF-TP-B\nCRF-TUBE\nCRF-TUBE-B\nCRF-U1007P\nCRF-U1007P-B\nCRF-U1007S\nCRF-U1007S-B\nCRF-U1010\nCRF-U1010-B\nCRF-U1010L\nCRF-U1010L-B\nCRF-U1010P\nCRF-U1010P-B\nCRF-U1010S\nCRF-U1010S-B\nCRF-U1015P\nCRF-U1015P-B\nCRF-U1015S\nCRF-U1015S-B\nCRF-U1020\nCRF-U1020-B\nCRF-U1020L\nCRF-U1020L-B\nCRF-U1020P\nCRF-U1020P-B\nCRF-U1020S\nCRF-U1020S-B\nCRF-U1025\nCRF-U1025-B\nCRF-U1030\nCRF-U1030-B\nCRF-U1030L\nCRF-U1030L-B\nCRF-U1030P\nCRF-U1030P-B\nCRF-U1030S\nCRF-U1030S-B\nCRF-U1040\nCRF-U1040-B\nCRF-U1040L\nCRF-U1040L-B\nCRF-U1040P\nCRF-U1040P-B\nCRF-U1050\nCRF-U1050-B\nCRF-U1050L\nCRF-U1050L-B\nCRF-U1050P\nCRF-U1050P-B\nCRF-U1507\nCRF-U1507-B\nCRF-U1507P\nCRF-U1507P-B\nCRF-U1507S\nCRF-U1507S-B\nCRF-U1510\nCRF-U1510-B\nCRF-U1510L\nCRF-U1510L-B\nCRF-U1510P\nCRF-U1510P-B\nCRF-U1510S\nCRF-U1510S-B\nCRF-U1515P\nCRF-U1515P-B\nCRF-U1515S\nCRF-U1515S-B\nCRF-U1520\nCRF-U1520-B\nCRF-U1520L\nCRF-U1520L-B\nCRF-U1520P\nCRF-U1520P-B\nCRF-U1520S\nCRF-U1520S-B\nCRF-U1525\nCRF-U1525-B\nCRF-U1530\nCRF-U1530-B\nCRF-U1530L\nCRF-U1530L-B\nCRF-U1530P\nCRF-U1530P-B\nCRF-U1530S\nCRF-U1530S-B\nCRF-U1535\nCRF-U1535-B\nCRF-U1535L\nCRF-U1535L-B\nCRF-U1540\nCRF-U1540-B\nCRF-U1540L\nCRF-U1540L-B\nCRF-U1540P\nCRF-U1540P-B\nCRF-U1545\nCRF-U1545-B\nCRF-U1545L\nCRF-U1545L-B\nCRF-U1550\nCRF-U1550-B\nCRF-U1550L\nCRF-U1550L-B\nCRF-U1550P\nCRF-U1550P-B\nCRF-U2007S\nCRF-U2007S-B\nCRF-U2010\nCRF-U2010-B\nCRF-U2010L\nCRF-U2010L-B\nCRF-U2010P\nCRF-U2010P-B\nCRF-U2010S\nCRF-U2010S-B\nCRF-U2015P\nCRF-U2015P-B\nCRF-U2015S\nCRF-U2015S-B\nCRF-U2020\nCRF-U2020-B\nCRF-U2020L\nCRF-U2020L-B\nCRF-U2020P\nCRF-U2020P-B\nCRF-U2020S\nCRF-U2020S-B\nCRF-U2025\nCRF-U2025-B\nCRF-U2030\nCRF-U2030-B\nCRF-U2030L\nCRF-U2030L-B\nCRF-U2030P\nCRF-U2030P-B\nCRF-U2030S\nCRF-U2030S-B\nCRF-U2035\nCRF-U2035-B\nCRF-U2035L\nCRF-U2035L-B\nCRF-U2040\nCRF-U2040-B\nCRF-U2040L\nCRF-U2040L-B\nCRF-U2040P\nCRF-U2040P-B\nCRF-U2045\nCRF-U2045-B\nCRF-U2045L\nCRF-U2045L-B\nCRF-U2050\nCRF-U2050-B\nCRF-U2050L\nCRF-U2050L-B\nCRF-U2050P\nCRF-U2050P-B\nCRF-U2510\nCRF-U2510-B\nCRF-U2510L\nCRF-U2510L-B\nCRF-U2510P\nCRF-U2510P-B\nCRF-U2520\nCRF-U2520-B\nCRF-U2520L\nCRF-U2520L-B\nCRF-U2520P\nCRF-U2520P-B\nCRF-U2530\nCRF-U2530-B\nCRF-U2530L\nCRF-U2530L-B\nCRF-U2530P\nCRF-U2530P-B\nCRF-U2535\nCRF-U2535-B\nCRF-U2535L\nCRF-U2535L-B\nCRF-U2540\nCRF-U2540-B\nCRF-U2540L\nCRF-U2540L-B\nCRF-U2540P\nCRF-U2540P-B\nCRF-U2545\nCRF-U2545-B\nCRF-U2545L\nCRF-U2545L-B\nCRF-U2550\nCRF-U2550-B\nCRF-U2550L\nCRF-U2550L-B\nCRF-U2550P\nCRF-U2550P-B"},{"_id":13,"device_name":"Shenzhen New Industries Biochemical Engineering Maglumi Aldosterone (CLIA) ","description":"The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Aldosterone (ALD) in human serum, plasma and urine using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrated System, and the assay is used for an aid in the diagnosis and treatment of individuals with suspected or confirmed primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance. ","gmdn_term":"Aldosterone IVD, kit, chemiluminescent immunoassay","medical_speciality_area":"Clinical chemistry","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251028B0002","registration_date":"28/10/2025 15:42","change_notification_approval_date":null,"retention_due_date":"27/10/2026 0:00","product_owner_name":"Shenzhen New Industries Biomedical Engineering Co., Ltd. ","product_owner_short_name":"Shenzhen New Industries Biomedical Engineering Co., Ltd. ","product_owner_address":"No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R. China, China","registrant_name":"NOVA DIAGNOSTICS PTE. LTD.","registrant_address":"28, SENANG CRESCENT, #03-12, BIZHUB28, Singapore 416601","importer_name":"NOVA DIAGNOSTICS PTE. LTD.","importer_address":"28, SENANG CRESCENT, #03-12, BIZHUB28, Singapore 416601","model_name":"MAGLUMI X3\nMAGLUMI Aldosterone (CLIA)\nMAGLUMI Aldosterone (CLIA)\nMAGLUMI Aldosterone (CLIA)\nMAGLUMI Aldosterone (CLIA) Controls","model_identifier":"010101003301\n130256007M\n130656007M\n130756007M\n160201295MT"},{"_id":14,"device_name":"BD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle","description":"The Multiple Sample Blood Collection Needle is intended for medical purposes to use with vacuum tubes for venous blood collection from a venous puncture. It is single-use and shall be disposed of into an approved medical waste container after use.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251028A0001","registration_date":"28/10/2025 14:41","change_notification_approval_date":null,"retention_due_date":"27/10/2026 0:00","product_owner_name":"Berpu Medical Technology Co., Ltd","product_owner_short_name":"Berpu Medical Technology Co., Ltd","product_owner_address":"No. 14 Xingji Road, Yongxing Street, Longwan District, 325000 Wenzhou, Zhejiang Province, PEOPLE'S REPUBLIC OF CHINA, China","registrant_name":"BECTON DICKINSON HOLDINGS PTE. LTD.","registrant_address":"10, COLLYER QUAY, #10-01, OCEAN FINANCIAL CENTRE, Singapore 049315","importer_name":"BECTON DICKINSON HOLDINGS PTE. LTD.","importer_address":"10, COLLYER QUAY, #10-01, OCEAN FINANCIAL CENTRE, Singapore 049315","model_name":"BD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle\nBD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle\nBD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle\nBD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle\nBD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle\nBD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle\nBD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle\nBD Vacutainer® PrecisionGlide™ Multiple Sample Blood Collection Needle","model_identifier":"360220\n360221\n360222\n360223\n360224\n360225\n360226\n360227"},{"_id":15,"device_name":"Image Management","description":"Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems.\nThe device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251027B0003","registration_date":"27/10/2025 18:09","change_notification_approval_date":null,"retention_due_date":"26/10/2026 0:00","product_owner_name":"Philips Medical Systems Nederland B.V.","product_owner_short_name":"Philips Medical Systems Nederland B.V.","product_owner_address":"Veenpluis 6, 5684 PC Best, Netherlands","registrant_name":"PHILIPS ELECTRONICS SINGAPORE PTE LTD","registrant_address":"622, LORONG 1 TOA PAYOH, #-, Singapore 319763","importer_name":"PHILIPS ELECTRONICS SINGAPORE PTE LTD","importer_address":"622, LORONG 1 TOA PAYOH, #L3-NA, Singapore 319763","model_name":"Image Management \nWeb Diagnostic Viewer \nEnterprise Viewer ","model_identifier":"839060\n839063\n839064"},{"_id":16,"device_name":"WSAUD SIGNIA INSIO C&G IX CIC HEARING AIDS (WIRELESS, DIGITAL)","description":"Hearing instruments are intended to improve the hearing of hearing impaired persons. Diagnosis and prescription of a hearing instrument must be performed by hearing health specialists, e.g. acousticians, audiologists or ENT doctors.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251027A0002","registration_date":"27/10/2025 14:52","change_notification_approval_date":null,"retention_due_date":"26/10/2026 0:00","product_owner_name":"WSAUD A/S","product_owner_short_name":"WSAUD A/S","product_owner_address":"NYMOELLEVEJ 6\nDK-3540 LYNGE\nDENMARK, Denmark","registrant_name":"SIVANTOS PTE. LTD.","registrant_address":"18, TAI SENG STREET, #08-08, 18 TAI SENG, Singapore 539775","importer_name":"SIVANTOS PTE. LTD.; WS AUDIOLOGY SEA PTE. LTD.","importer_address":"18, TAI SENG STREET, #08-08, 18 TAI SENG, Singapore 539775","model_name":"INSIO C&G 7IX CIC (thickness= 50µm - 100µm)\nINSIO C&G 5IX CIC (thickness= 50µm - 100µm)\nINSIO C&G 3IX CIC (thickness= 50µm - 100µm)\nINSIO C&G 2IX CIC (thickness= 50µm - 100µm)\nINSIO C&G 1IX CIC (thickness= 50µm - 100µm)","model_identifier":"21050784\n21050785\n21050786\n21050787\n21050788"},{"_id":17,"device_name":"Oncosoft OncoStudio","description":"OncoStudio provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images. This software could be used as an initial contouring for the clinicians to be confirmed by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.\n• Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis\n• Generates DICOM-RT structure of contoured objects\n• Manual Contouring\n• Receive, transmit, store, retrieve, display, and process medical images and DICOM objects","gmdn_term":null,"medical_speciality_area":"Radiology / Imaging","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251027Z0001","registration_date":"27/10/2025 10:23","change_notification_approval_date":null,"retention_due_date":"26/10/2026 0:00","product_owner_name":"Oncosoft Inc.","product_owner_short_name":"Oncosoft Inc.","product_owner_address":"2F, 3F, 4F, 37, Myeongmul-gil, Seodaemun-gu, Seoul, Korea, South","registrant_name":"ANDAMAN MEDICAL PTE. LTD.","registrant_address":", 300 TAMPINES AVENUE 5, #09-02, NTUC INCOME TAMPINES JUNCTION, Singapore 529653","importer_name":null,"importer_address":null,"model_name":"OncoStudio","model_identifier":"OS-01"},{"_id":18,"device_name":"Arthrex Knotless Mini TightRope Implant System","description":"Intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Intended to provide fixation during the healing process following:\n• Hallux valgus reconstruction by providing for the reduction of 1st metatarsal-2nd metatarsal intermetatarsal angle\n• Tarsometatarsal injury, such as fixation of foot soft tissue separations due to a Lisfranc injury\n• Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament disruptions\nArthrex Mini TightRope when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Indicated for carpal metacarpal joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. It is also indicated for use as adjuncts in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.","gmdn_term":"Polyester suture, non-bioabsorbable, multifilament","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251026Y0001","registration_date":"26/10/2025 10:24","change_notification_approval_date":null,"retention_due_date":"25/10/2026 0:00","product_owner_name":"Arthrex, Inc.","product_owner_short_name":"Arthrex, Inc.","product_owner_address":"1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States","registrant_name":"ARTHREX SINGAPORE, PTE. LTD.","registrant_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","importer_name":"ARTHREX SINGAPORE, PTE. LTD.","importer_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","model_name":"Knotless Mini TightRope® Implant System, 1.1 mm, Titanium\nKnotless Mini TightRope® Implant System, 1.1 mm, Dual-Fixation, Titanium\nKnotless Mini TightRope® Implant System, 2.7 mm, Titanium\n1.1 mm Suture Passing K-Wire","model_identifier":"AR-8906DS\nAR-8907DS\nAR-8908DS\nAR-8914K"},{"_id":19,"device_name":"VIZIONFOCUS candymagic Blue Light Barrier 1day color contact lenses","description":"Indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.","gmdn_term":null,"medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024E0018","registration_date":"24/10/2025 15:28","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"VIZIONFOCUS INC.","product_owner_short_name":"VIZIONFOCUS INC.","product_owner_address":"3F., No.66, Youyi Rd., Zhunan Township, Miaoli County 350, Taiwan","registrant_name":"QUALTECH CONSULTING CORPORATION PTE. LTD.","registrant_address":"111, NORTH BRIDGE ROAD, #21-01, PENINSULA PLAZA, Singapore 179098","importer_name":null,"importer_address":null,"model_name":"candymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)\ncandymagic Blue Light Barrier 1day color contact lenses\n(+20.00D to +0.25D, -0.25D to -20.00D)\n(pack of 1 to 100)","model_identifier":"Candy magic, UV, Black Double Color\nCandy magic, UV, Black Mica double Color\nCandy magic, UV, Black Mica Single Color\nCandy magic, UV, Black Mica Three Color\nCandy magic, UV, Black Single Color\nCandy magic, UV, Black Three Color\nCandy magic, UV, Blue Double Color\nCandy magic, UV, Blue Mica double Color\nCandy magic, UV, Blue Mica Single Color\nCandy magic, UV, Blue Mica Three Color\nCandy magic, UV, Blue Single Color\nCandy magic, UV, Blue Three Color\nCandy magic, UV, Brown Double Color\nCandy magic, UV, Brown Mica double Color\nCandy magic, UV, Brown Mica Single Color\nCandy magic, UV, Brown Mica Three Color\nCandy magic, UV, Brown Single Color\nCandy magic, UV, Brown Three Color\nCandy magic, UV, Gold Double Color\nCandy magic, UV, Gold Mica double Color\nCandy magic, UV, Gold Mica Single Color\nCandy magic, UV, Gold Mica Three Color\nCandy magic, UV, Gold Single Color\nCandy magic, UV, Gold Three Color\nCandy magic, UV, Gray Double Color\nCandy magic, UV, Gray Mica double Color\nCandy magic, UV, Gray Mica Single Color\nCandy magic, UV, Gray Mica Three Color\nCandy magic, UV, Gray Single Color\nCandy magic, UV, Gray Three Color\nCandy magic, UV, Green Double Color\nCandy magic, UV, Green Mica double Color\nCandy magic, UV, Green Mica Single Color\nCandy magic, UV, Green Mica Three Color\nCandy magic, UV, Green Single Color\nCandy magic, UV, Green Three Color\nCandy magic, UV, Pink Double Color\nCandy magic, UV, Pink Mica double Color\nCandy magic, UV, Pink Mica Single Color\nCandy magic, UV, Pink Mica Three Color\nCandy magic, UV, Pink Single Color\nCandy magic, UV, Pink Three Color\nCandy magic, UV, Violet Double Color\nCandy magic, UV, Violet Mica double Color\nCandy magic, UV, Violet Mica Single Color\nCandy magic, UV, Violet Mica Three Color\nCandy magic, UV, Violet Single Color\nCandy magic, UV, Violet Three Color"},{"_id":20,"device_name":"Spineart JULIET ® PO/OL/TL Lumbar PEEK Cage","description":"JULIET® PO/OL/TL is a product intended for use during lumbar discectomy with fusion. The JULIET® PEEK range is indicated for discectomy with fusion of the lumbar spine at one level or two contiguous levels from L2 to S1 in patients with: • Degenerative pathology, including symptomatic disc degeneration, recurrent disc herniation, degenerative spondylolisthesis; • Low grade isthmic spondylolisthesis; • Lumbar canal and foraminal stenosis; These patients should be skeletally mature. Supplemental fixation/stabilization as well as additional bone grafting material is required.","gmdn_term":"Polymeric spinal interbody fusion cage","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024D0017","registration_date":"24/10/2025 12:25","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Spineart SA","product_owner_short_name":"Spineart SA","product_owner_address":"3 Chemin du Pré-Fleuri, 1228, Plan-les-Ouates, Switzerland","registrant_name":"TRANSMEDIC PTE LTD","registrant_address":"5, JALAN KILANG BARAT, #09-00, PETRO CENTRE, Singapore 159349","importer_name":"TRANSMEDIC PTE LTD","importer_address":"5, JALAN KILANG BARAT, #09-00, PETRO CENTRE, Singapore 159349","model_name":"Juliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H08 0°\nJuliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H10 0°\nJuliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H12 0°\nJuliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H14 0°\nJuliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H08 05°\nJuliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H10 05°\nJuliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H12 05°\nJuliet ® PO Posterior Lumbar Peek Cage L22 W10.5 H14 05°\nJuliet ® PO Posterior Lumbar Peek Extra Lordotic Cage L22 W10.5 H08 09°\nJuliet ® PO Posterior Lumbar Peek Extra Lordotic Cage L22 W10.5 H10 12°\nJuliet ® PO Posterior Lumbar Peek Extra Lordotic Cage L22 W10.5 H12 12°\nJuliet ® PO Posterior Lumbar Peek Extra Lordotic Cage L22 W10.5 H14 12°\nJuliet ® TL Transforaminal Lumbar Peek Cage L28 W11 H08 04°\nJuliet ® TL Transforaminal Lumbar Peek Cage L28 W11 H10 04°\nJuliet ® TL Transforaminal Lumbar Peek Cage L28 W11 H12 04°\nJuliet ® TL Transforaminal Lumbar Peek Cage L28 W11 H14 04°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H07\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H08\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H10\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H12\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H14\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H07\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H08\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H10\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H12\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H14\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H07 09°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H08 12°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H10 12°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H12 12°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L28 W10.5 H14 12°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H07 09°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H08 12°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H10 12°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H12 12°\nJuliet ® OL Straight Transforaminal Lumbar Peek Cage L32 W10.5 H14 12°","model_identifier":"DYN-P0 22 08-S\nDYN-P0 22 10-S\nDYN-P0 22 12-S\nDYN-P0 22 14-S\nDYN-P5 22 08-S\nDYN-P5 22 10-S\nDYN-P5 22 12-S\nDYN-P5 22 14-S\nDYN-PX 22 08-S\nDYN-PX 22 10-S\nDYN-PX 22 12-S\nDYN-PX 22 14-S\nDYN-TL 04 08-S\nDYN-TL 04 10-S\nDYN-TL 04 12-S\nDYN-TL 04 14-S\nJUL-OL 28 07-S\nJUL-OL 28 08-S\nJUL-OL 28 10-S\nJUL-OL 28 12-S\nJUL-OL 28 14-S\nJUL-OL 32 07-S\nJUL-OL 32 08-S\nJUL-OL 32 10-S\nJUL-OL 32 12-S\nJUL-OL 32 14-S\nJUL-OX 28 07-S\nJUL-OX 28 08-S\nJUL-OX 28 10-S\nJUL-OX 28 12-S\nJUL-OX 28 14-S\nJUL-OX 32 07-S\nJUL-OX 32 08-S\nJUL-OX 32 10-S\nJUL-OX 32 12-S\nJUL-OX 32 14-S"},{"_id":21,"device_name":"OMRON Automatic Blood Pressure Monitor (EZ Series)","description":"This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and indicates this via a symbol with the measurement result.","gmdn_term":"Blood pressure cuff, reusable","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024C0016","registration_date":"24/10/2025 12:22","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"OMRON HEALTHCARE Co., Ltd","product_owner_short_name":"OMRON HEALTHCARE Co., Ltd","product_owner_address":"53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002, Japan","registrant_name":"OMRON HEALTHCARE SINGAPORE PTE LTD","registrant_address":"438B, ALEXANDRA ROAD, #08-01/02, ALEXANDRA TECHNOPARK, Singapore 119968","importer_name":"OMRON HEALTHCARE SINGAPORE PTE LTD","importer_address":"438B, ALEXANDRA ROAD, #08-01/02, ALEXANDRA TECHNOPARK, Singapore 119968","model_name":"OMRON Automatic Blood Pressure Monitor EZ\nOMRON Automatic Blood Pressure Monitor EZ Power\nOMRON Automatic Blood Pressure Monitor EZ Large\nOMRON Automatic Blood Pressure Monitor EZ BT\nOMRON Automatic Blood Pressure Monitor EZ BT Power\nOMRON Automatic Blood Pressure Monitor EZ BT Large","model_identifier":"HEM-7183\nHEM-7183-C\nHEM-7183-L\nHEM-7183T1\nHEM-7183T1-C\nHEM-7183T1-L"},{"_id":22,"device_name":"Arthrex Knotless Acromioclavicular (AC) TightRope Repair","description":"The Arthrex Knotless Acromioclavicular (AC) TightRope Repair devices are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.\nThe Arthrex Knotless Acromioclavicular (AC) TightRope Repair devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption. \nThe Arthrex Knotless Acromioclavicular (AC) TightRope Repair devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.","gmdn_term":"Polyester suture, non-bioabsorbable, multifilament","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024B0015","registration_date":"24/10/2025 12:11","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Arthrex, Inc.","product_owner_short_name":"Arthrex, Inc.","product_owner_address":"1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States","registrant_name":"ARTHREX SINGAPORE, PTE. LTD.","registrant_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","importer_name":"ARTHREX SINGAPORE, PTE. LTD.","importer_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","model_name":"Knotless AC TightRope® Repair Implant with Dog Bone™ Button, Clavicle Cup Button Implant, Dog Bone Button\nKnotless AC TightRope® Repair System, Clavicle Cup Button Implant, Dog Bone™ Button, 3.0 mm Cannulated Drill, Nitinol Wire Loop\nKnotless AC TightRope® Open Repair Implant, Clavicle Cup Button Implant, Pec Button","model_identifier":"AR-2370BL\nAR-2371BL\nAR-2372BLO"},{"_id":23,"device_name":"Episurf Episealer Knee System","description":"The Episealer Knee Implant (hereinafter also referred to as Episealer) is an individualised endoprosthetic resurfacing implant, intended to be used as a cartilage and bone replacement for knee condyle chondral, knee trochlea chondral, femoral knee joint chondral and/or osteochondral defects, covering a part of the joint. It is intended to give the patient improved knee function and relief of pain. It is applicable on the femoral knee joint, for different lesion sizes and lesions of degenerative or traumatic etiology.","gmdn_term":"Transfemoral amputation tissue-reinforcement implant","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024A0014","registration_date":"24/10/2025 12:10","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Episurf Operations AB","product_owner_short_name":"Episurf Operations AB","product_owner_address":"Karlavagen 60, 114 49 Stockholm, Sweden","registrant_name":"HUMEDICAL (S) PTE. LTD.","registrant_address":"3791, JALAN BUKIT MERAH, #06-17, E-CENTRE @ REDHILL, Singapore 159471","importer_name":"HUMEDICAL (S) PTE. LTD.","importer_address":"3791, JALAN BUKIT MERAH, #06-17, E-CENTRE @ REDHILL, Singapore 159471","model_name":"Episealer Condyle Solo, Diameter = 12 mm\nLength = 18-24 mm\nEpisealer Condyle Solo, Diameter = 12 mm, Length = 18-24 mm\nEpisealer Condyle Solo, Diameter = 15 mm\nLength = 18-24 mm\nEpisealer Condyle Solo, Diameter = 15 mm, Length = 18-24 mm\nEpisealer Condyle Solo, Diameter = 17 mm\nLength = 18-24 mm\nEpisealer Condyle Solo, Diameter = 17 mm, Length = 18-24 mm\nEpisealer Condyle Solo, Diameter = 20 mm\nLength = 18-24 mm\nEpisealer Condyle Solo, Diameter = 20 mm, Length = 18-24 mm\nEpidrill, Diameter = 11,8 (15,8 hat) mm\nLength = 87,7 mm\nEpidrill,Diameter = 11,8 (15,8 hat) mm\nLength = 87,7 mm\nEpidrill, Diameter = 14,8 (18,8 hat) mm\nLength = 87,7 mm\nEpidrill, Diameter = 14,8 (18,8 hat) mm\nLength = 87,7 mm\nEpidrill, Diameter = 16,8 (20,8 hat) mm\nLength = 87,7 mm\nEpidrill, Diameter = 16,8 (20,8 hat) mm\nLength = 87,7 mm\nEpidrill, Diameter = 19,8 (23,8 hat) mm\nLength = 87,7 mm\nEpidrill, Diameter = 19,8 (23,8 hat) mm\nLength = 87,7 mm\nDrilling Socket, Diameter = 22 mm\nLength = 42 mm\nDrilling Socket, Diameter = 22 mm\nLength = 42 mm\nDrilling Socket, Diameter = 25 mm\nLength = 42 mm\nDrilling Socket, Diameter = 25 mm\nLength = 42 mm\nDrilling Socket, Diameter = 27 mm\nLength = 42 mm\nDrilling Socket, Diameter = 27 mm\nLength = 42 mm\nDrilling Socket, Diameter = 30 mm\nLength = 42 mm\nDrilling Socket, Diameter = 30 mm\nLength = 42 mm\nAdjustment Socket, Diameter = 22 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 22 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 25 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 25 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 27 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 27 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 30 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 30 mm\nLength = 26 mm\nEpidummy, Diameter = 11,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 11,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 14,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 14,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 16,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 16,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 19,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 19,60 mm\nLength = 108,30 mm\nEpimandrel, Diameter = 11 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 11 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 14 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 14 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 16 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 16 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 19 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 19 mm\nLength = 130-150 mm\nEpisealer Trochlea Solo, Diameter = 20 mm\nLength = 18-35 mm\nEpisealer Trochlea Solo, Diameter = 20 mm, Length = 18-35 mm\nEpisealer Trochlea Sol , Diameter = 25 mm\nLength = 18-35 mm\nEpisealer Trochlea Sol , Diameter = 25 mm, Length = 18-35 mm\nEpisealer Trochlea Solo, Diameter = 29 mm\nLength = 18-35 mm\nEpisealer Trochlea Solo, Diameter = 29 mm, Length = 18-35 mm\nEpidrill, Diameter = 19,8 (23,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 19,8 (23,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 24,8 (28,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 24,8 (28,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 28,5 (32,5 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 28,5 (32,5 hat) mm\nLength = 99,1 mm\nDrilling Socket, Diameter = 30 mm\nLength = 42 mm\nDrilling Socket, Diameter = 30 mm\nLength = 42 mm\nDrilling Socket, Diameter = 35 mm\nLength = 42 mm\nDrilling Socket, Diameter = 35 mm\nLength = 42 mm\nDrilling Socket, Diameter = 39 mm\nLength = 42 mm\nDrilling Socket, Diameter = 39 mm\nLength = 42 mm\nAdjustment Socket, Diameter = 30 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 30 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 35 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 35 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 39 mm\nLength = 26 mm\nAdjustment Socket, Diameter = 39 mm\nLength = 26 mm\nEpidummy, Diameter = 19,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 19,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 24,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 24,60 mm\nLength = 108,30 mm\nEpidummy, Diameter = 28,34 mm\nLength = 108,30 mm\nEpidummy, Diameter = 28,34 mm\nLength = 108,30 mm\nEpimandrel, Diameter = 19 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 19 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 24 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 24 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 28 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 28 mm\nLength = 130-150 mm\nEpisealer Femoral Twin, Width 15 mm\nStretch = 23 mm\nLength = 18-35 mm\nEpisealer Femoral Twin, Width 15 mm, Stretch = 23 mm, Length = 18-35 mm\nEpisealer Femoral Twin, Diameter = 17 mm\nStretch = 26 mm\nLength = 18-35 mm\nEpisealer Femoral Twin, Diameter = 17 mm, Stretch = 26 mm, Length = 18-35 mm\nEpisealer Femoral Twin, Diameter = 20 mm\nStretch = 29 mm\nLength = 18-35 mm\nEpisealer Femoral Twin, Diameter = 20 mm, Stretch = 29 mm, Length = 18-35 mm\nEpisealer Femoral Twin, Diameter = 25 mm\nStretch = 35 mm\nLength = 18-35 mm\nEpisealer Femoral Twin, Diameter = 25 mm, Stretch = 35 mm, Length = 18-35 mm\nEpidrill, Diameter = 14,8 (18,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 14,8 (18,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 16,8 (20,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 16,8 (20,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 19,8 (23,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 19,8 (23,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 24,8 (28,8 hat) mm\nLength = 99,1 mm\nEpidrill, Diameter = 24,8 (28,8 hat) mm\nLength = 99,1 mm\nDrilling Socket, Diameter = 25 mm\nLength = 42 mm\nDrilling Socket, Diameter = 25 mm\nLength = 42 mm\nDrilling Socket, Diameter = 27 mm\nLength = 42 mm\nDrilling Socket, Diameter = 27 mm\nLength = 42 mm\nDrilling Socket, Diameter = 30 mm\nLength = 42 mm\nDrilling Socket, Diameter = 30 mm\nLength = 42 mm\nDrilling Socket, Diameter = 35 mm\nLength = 42 mm\nDrilling Socket, Diameter = 35 mm\nLength = 42 mm\nAdjusment Socket, Diameter = 25 mm\nLength = 26 mm\nAdjusment Socket, Diameter = 25 mm\nLength = 26 mm\nAdjusment Socket, Diameter = 27 mm\nLength = 26 mm\nAdjusment Socket, Diameter = 27 mm\nLength = 26 mm\nAdjusment Socket, Diameter = 30 mm\nLength = 26 mm\nAdjusment Socket, Diameter = 30 mm\nLength = 26 mm\nAdjusment Socket, Diameter = 35 mm\nLength = 26 mm\nAdjusment Socket, Diameter = 35 mm\nLength = 26 mm\nEpidummy, Diameter = 14,60 mm\nStretch = 21,78 mm\nLength = 106,60 mm\nEpidummy, Diameter = 14,60 mm\nStretch = 21,78 mm\nLength = 106,60 mm\nEpidummy, Diameter = 16,60 mm\nStretch = 24,82 mm\nLength = 109,60 mm\nEpidummy, Diameter = 16,60 mm\nStretch = 24,82 mm\nLength = 109,60 mm\nEpidummy, Diameter = 19,60 mm\nStretch = 27,82 mm\nLength = 109,60 mm\nEpidummy, Diameter = 19,60 mm\nStretch = 27,82 mm\nLength = 109,60 mm\nEpidummy, Diameter = 24,60 mm\nStretch = 33,82 mm\nLength = 109,60 mm\nEpidummy, Diameter = 24,60 mm\nStretch = 33,82 mm\nLength = 109,60 mm\nEpimandrel, Diameter = 14 mm\nStretch = 22 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 14 mm\nStretch = 22 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 16 mm\nStretch = 25 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 16 mm\nStretch = 25 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 19 mm\nStretch = 28 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 19 mm\nStretch = 28 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 24 mm\nStretch = 34 mm\nLength = 130-150 mm\nEpimandrel, Diameter = 24 mm\nStretch = 34 mm\nLength = 130-150 mm","model_identifier":"11112\n11112 (Diameter = 12 mm, Length = 18-24 mm)\n11115\n11115 (Diameter = 15 mm, Length = 18-24 mm)\n11117\n11117 (Diameter = 17 mm, Length = 18-24 mm)\n11120\n11120 (Diameter = 20 mm, Length = 18-24 mm)\n12112\n12112N\n12115\n12115N\n12117\n12117N\n12120\n12120N\n13112\n13112N\n13115\n13115N\n13117\n13117N\n13120\n13120N\n13412\n13412N\n13415\n13415N\n13417\n13417N\n13420\n13420N\n14112\n14112N\n14115\n14115N\n14117\n14117N\n14120\n14120N\n17312\n17312N\n17315\n17315N\n17317\n17317N\n17320\n17320N\n31120\n31120 (Diameter = 20 mm, Length = 18-35 mm)\n31125\n31125 (Diameter = 25 mm, Length = 18-35 mm)\n31129\n31129 (Diameter = 29 mm, Length = 18-35 mm)\n32120\n32120N\n32125\n32125N\n32129\n32129N\n33120\n33120N\n33125\n33125N\n33129\n33129N\n33420\n33420N\n33425\n33425N\n33429\n33429N\n34120\n34120N\n34125\n34125N\n34129\n34129N\n37320\n37320N\n37325\n37325N\n37329\n37329N\n51115\n51115 (Width 15 mm, Stretch = 23 mm, Length = 18-35 mm)\n51117\n51117 (Diameter = 17 mm, Stretch = 26 mm, Length = 18-35 mm)\n51120\n51120 (Diameter = 20 mm, Stretch = 29 mm, Length = 18-35 mm)\n51125\n51125 (Diameter = 25 mm, Stretch = 35 mm, Length = 18-35 mm)\n52115\n52115N\n52117\n52117N\n52120\n52120N\n52125\n52125N\n53115\n53115N\n53117\n53117N\n53120\n53120N\n53125\n53125N\n53415\n53415N\n53417\n53417N\n53420\n53420N\n53425\n53425N\n54115\n54115N\n54117\n54117N\n54120\n54120N\n54125\n54125N\n57315\n57315N\n57317\n57317N\n57320\n57320N\n57325\n57325N"},{"_id":24,"device_name":"START Auto Refractometer SRK-70","description":"The product is the precise instrument to measure objectively the parameter of diopter and corneal curvature, suitable for patient measurement of Spherical, Cylindrical, Axis, PD and Corneal Radius of Curvature.","gmdn_term":"Automated ophthalmic refractometer","medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024Z0013","registration_date":"24/10/2025 12:09","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Shanghai Supore Instruments Co., Ltd.","product_owner_short_name":"Shanghai Supore Instruments Co., Ltd.","product_owner_address":"No.800 Yeji Road, Baoshang District, Shanghai 200444, China, China","registrant_name":"ESSILOR SINGAPORE","registrant_address":"201, KALLANG BAHRU, #02-02, ESSILORLUXOTTICA BUILDING, Singapore 339338","importer_name":"ESSILOR SINGAPORE","importer_address":"201, KALLANG BAHRU, #02-02, ESSILORLUXOTTICA BUILDING, Singapore 339338","model_name":"START Auto Refractometer SRK-70","model_identifier":"SRK-70"},{"_id":25,"device_name":"Sentec tCOM+","description":"The tCOM+ is a portable stand-alone patient monitor indicated for continuous, non-invasive patient monitoring of carbon dioxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using digital sensor (V-Sign™ Sensor2).Transcutaneous PCO2 monitoring is indicated in adult/pediatric (older than term birth plus 12 months) and neonatal (younger than term birth plus 12 months) patients. Pulse oximetry monitoring is indicated in adult/pediatric patients only.","gmdn_term":"Patient monitoring system module, multifunction","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024Y0012","registration_date":"24/10/2025 12:05","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"SenTec AG","product_owner_short_name":"SenTec AG","product_owner_address":"Ringstrasse 39, CH-4106 Therwil, Switzerland","registrant_name":"JUNNIMED SERVICES PTE. LTD.","registrant_address":"17, KAKI BUKIT PLACE, #---, EUNOS TECHPARK, Singapore 416195","importer_name":"JUNNIMED SERVICES PTE. LTD.","importer_address":"17, KAKI BUKIT PLACE, #---, EUNOS TECHPARK, Singapore 416195","model_name":"tCOM+\nV-STATS™\nV-Sign™ Sensor 2","model_identifier":"103164\nV-STATS_CD\nVS-A/P/N"},{"_id":26,"device_name":"Gynemed GM508 CultActive","description":"GM508 CultActive is a bicarbonate-buffered reagent designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. GM508 CultActive is designed to investigate if fertilization failure after previous ICSI-cycles is due to a deficient oocyte activation. The intended users are IVF professionals (lab technicians, embryologists or medical doctors).","gmdn_term":"IVF medium","medical_speciality_area":"Obstetrics & Gynaecology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024X0011","registration_date":"24/10/2025 12:02","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Gynemed GmbH & Co. KG","product_owner_short_name":"Gynemed GmbH & Co. KG","product_owner_address":"Wagrienring 24b, 23730 Sierksdorf, Germany","registrant_name":"LABGISTICS ASIA PTE. LTD.","registrant_address":"76, PIONEER ROAD, #03-05, MAPLETREE PIONEER LOGISTICS HUB, Singapore 639577","importer_name":"LABGISTICS ASIA PTE. LTD.","importer_address":"76, PIONEER ROAD, #03-05, MAPLETREE PIONEER LOGISTICS HUB, Singapore 639577","model_name":"GM508 CultActive","model_identifier":"4 GM 508CULT-active1"},{"_id":27,"device_name":"Cofoe Medical Blood Glucose Test Strip","description":"Blood glucose test strips are used in conjunction with blood glucose meters for in vitro monitoring of glucose concentration in human capillary whole blood. This product can be used by professionals, non-professionals suffering from diabetes who are skilled in this operation or their family members to monitor blood glucose at home or in medical units. The product is only used to monitor the effect of blood glucose control of diabetic patients and cannot be used as the basis for adjustment of therapeutic drugs. ","gmdn_term":"Glucose IVD, kit, rapid spectrophotometry, clinical","medical_speciality_area":"Hematology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024W0010","registration_date":"24/10/2025 12:01","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Cofoe Medical Technology Co., Ltd.","product_owner_short_name":"Cofoe Medical Technology Co., Ltd.","product_owner_address":"816 Zhenhua Road, Yuhua District, 410000 Changsha, Hunan, China","registrant_name":"BIOMED DIAGNOSTICS PTE LTD","registrant_address":"18, BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966","importer_name":"BIOMED DIAGNOSTICS PTE LTD","importer_address":"18, BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966","model_name":"Twist Lancet\nTwist Lancet\nCofoe BGM Test Strips\nBlood Glucose Test Strips\nBlood Glucose Meter\nBlood Glucose Meter\nBlood Glucose Meter\nGlucose Control Solution","model_identifier":"28G-25\n28G-50\nKF-A01-C-25\nKF-A01-C-50\nKF-A02-C\nKF-A06-C\nKF-A08-C\nPacking specification 1: Level 1 (3ml*1)"},{"_id":28,"device_name":"DENTSCARE FGM Condac 37% ","description":"Etching of the enamel and dentin to improve the adhesion of the restorative materials to the tooth.","gmdn_term":"Dental etching solution","medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024E0009","registration_date":"24/10/2025 12:01","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Dentscare Ltda.","product_owner_short_name":"Dentscare Ltda.","product_owner_address":"Av. Edgar Nelson Meister, 474, Joinville, Santa Catarina, 89219-501, Brazil","registrant_name":"RDG SUPPLIES PTE. LTD.","registrant_address":"115A, Commonwealth Drive, #04-09, Tanglin Halt Industrial Estate, Singapore 149596","importer_name":"RDG SUPPLIES PTE. LTD.","importer_address":"115A, Commonwealth Drive, #04-09, Tanglin Halt Industrial Estate, Singapore 149596","model_name":"Condac 37%\nCondac 37%","model_identifier":"4000015482\n4000055782"},{"_id":29,"device_name":"NICO-LAB StrokeViewer","description":"StrokeViewer is an image processing software application that analyzes CT scans and MR perfusion scans of the brain to indicate areas of the brain of suspected stroke patients to indicate areas of the brain with suspected anterior circulation large vessel occlusion (LVO) or hemorrhagic stroke. Additionally, StrokeViewer performs calculations to quantify collateral circulation, brain perfusion, hemorrhagic stroke volume, and ASPECTS.\n\nStrokeViewer provides this information to the user to include it as additional data for diagnosis of stroke in suspected stroke patients for the adult population, and to determine treatment. There is no change to the standard of care assessment of suspected stroke patients where the healthcare professional assesses the medical images. StrokeViewer only provides additional imaging data and numerical data that may be taken into consideration by a healthcare professional. StrokeViewer is not intended to be used as a standalone diagnostic tool, and StrokeViewer output should always be interpreted in the context of clinical information about the patient rather than in isolation. The StrokeViewer output is provided as a DICOM report/series.\n\n\n","gmdn_term":"Clinical management support software","medical_speciality_area":"Radiology / Imaging","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024D0008","registration_date":"24/10/2025 11:59","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"NICO-LAB BV","product_owner_short_name":"NICO-LAB BV","product_owner_address":"Paasheuvelweg 25, Wing B6, 1105 BP Amsterdam, Netherlands","registrant_name":"ARQON PTE. LTD.","registrant_address":"221, HENDERSON ROAD, #02-08, HENDERSON BUILDING, Singapore 159557","importer_name":null,"importer_address":null,"model_name":"StrokeViewer","model_identifier":"STRKVWRBD"},{"_id":30,"device_name":"Medtrade FOXSEAL Vented Chest Seal Dressing for Open Chest Wounds","description":"Chest seal dressing for open chest wounds to prevent tension pneumothorax. For use by trained emergency responders only.","gmdn_term":"Pneumothorax dressing","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024C0007","registration_date":"24/10/2025 11:56","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Medtrade Products Ltd","product_owner_short_name":"Medtrade Products Ltd","product_owner_address":"Electra House\nCrewe Business Park\nCrewe, CW1 6GL\nUK, United Kingdom","registrant_name":"ARIS INTEGRATED MEDICAL PTE. LTD.","registrant_address":"18, HOWARD ROAD, #08-02, NOVELTY BIZCENTRE, Singapore 369585","importer_name":"ARIS INTEGRATED MEDICAL PTE. LTD.","importer_address":"18, HOWARD ROAD, #08-02, NOVELTY BIZCENTRE, Singapore 369585","model_name":"FOXSEAL Vented Chest Seal Dressing (CSD)","model_identifier":"FG08814601"},{"_id":31,"device_name":"Scivita Medical Single-use Video Cholangioscope","description":"Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories","gmdn_term":"Flexible video choledochoscope, single-use","medical_speciality_area":"Gastroenterology & Urology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024B0006","registration_date":"24/10/2025 11:55","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Scivita Medical Technology Co., Ltd.","product_owner_short_name":"Scivita Medical Technology Co., Ltd.","product_owner_address":"No.2 Qingqiu Street,, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Province, CHINA","registrant_name":"BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.","registrant_address":"9, NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS TOWER ONE, Singapore 138588","importer_name":"BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.","importer_address":"9, NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS TOWER ONE, Singapore 138588","model_name":"Full HD Endoscopic Image Processor\nFull HD Visualization Endoscopic Image Processor\nSingle-use Video Cholangioscope\nSingle-use Video Cholangioscope","model_identifier":"HDVS-S200D\nHDVS-S300D\nSCV-P-01G\nSCV-P-02G"},{"_id":32,"device_name":"Shanghai Bojin Bojin Medical Drill Bits","description":"It is intended for drilling, reaming, milling of a hole to size and depth in bone or tissue, has cutter and connecting interface, which can match with electric and pneumatic power tools. It is intended to be used by qualified healthcare professionals.","gmdn_term":"Fluted surgical drill bit, reusable","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024A0005","registration_date":"24/10/2025 11:54","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Shanghai Bojin Medical Instrument Co., Ltd.","product_owner_short_name":"Shanghai Bojin Medical Instrument Co., Ltd.","product_owner_address":"A Zone of F2, C Zone of F1,, Building 6, No. 125, Longpan Road, Jiading District, Shanghai, China, China","registrant_name":"QUEENMED ASIA PTE. LTD.","registrant_address":"10, TAMAN SERASI, #01-16, BOTANIC GARDEN MANSIONS, Singapore 257721","importer_name":"QUEENMED ASIA PTE. LTD.","importer_address":"10, TAMAN SERASI, #01-16, BOTANIC GARDEN MANSIONS, Singapore 257721","model_name":"Medical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits\nMedical Drill Bits","model_identifier":"BJXXZ-1.2/2.3-12.5-65\nBJXXZ-1.2/2.3-16-65\nBJXXZ-1.6/2.3-20-74\nBJXXZ-2.0-13-65\nBJXXZ-2.0-13-65\nBJXXZ-2.0-20-100\nBJXXZ-2.0-20-70\nBJXXZ-2.0-8-65\nBJXXZ-2.0-8-65\nBJXXZ-2.0-9-65\nBJXXZ-2.0-9-65\nBJXXZ-2.2/3-21-73.5\nBJXXZ-2.7-13.5-65\nBJXXZ-2.7/3.1-12.5-65\nBJXXZ-2.7/3.1-12.5-65\nBJXXZ-3.0-8-65\nBJXXZ-4.0-8-65\nBJXZ-2.0-12-65\nBJXZ-2.0-13-65\nBJXZ-2.0-20-70\nBJXZ-2.0-22.5-65\nBJXZ-2.5-30-65\nBJXZ-2.7-13.5-65\nBJXZ-3.1/4.1-12.5-65\nBJXZ-4.0-30-65"},{"_id":33,"device_name":"P2-E6 PORTABLE OXYGEN CONCENTRATOR","description":"The Portable Oxygen Concentrator is intended to provide supplemental oxygen. It is to be used in home healthcare environment included indoors, outdoors and in vehicles. This device is not intended to be life-supporting. The intended population for the use of Portable Oxygen Concentrator encompasses individuals with various respiratory conditions who require supplemental oxygen therapy to manage their symptoms and improve their quality of life. This device is for adult only.","gmdn_term":null,"medical_speciality_area":"Anaesthesiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024Z0004","registration_date":"24/10/2025 11:52","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Qingdao Kingon Medical Science and Technology Co., Ltd","product_owner_short_name":"Qingdao Kingon Medical Science and Technology Co., Ltd","product_owner_address":"24th Factory Building, NO. 252 Yanhe Road, Huangdao, Qingdao, Shandong, China, 266510, China","registrant_name":"AGIS MEDICAL SUPPLIES PTE. LTD.","registrant_address":"50, KALLANG PUDDING ROAD, #08-08, AMA BUILDING, Singapore 349326","importer_name":null,"importer_address":null,"model_name":"PORTABLE OXYGEN CONCENTRATOR P2-E6","model_identifier":"P2-E6"},{"_id":34,"device_name":"CooperSurgical PICSI Sperm Selection Device","description":"In the treatment of infertile couples by Intracytoplasmic\r\nSperm Injection (ICSI), the PICSI® Sperm Selection\r\nDevice is indicated for the selection of mature sperm for\r\ninjection.","gmdn_term":"Hyaluronan binding sperm selection device","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251024Y0003","registration_date":"24/10/2025 11:51","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"CooperSurgical Inc.","product_owner_short_name":"CooperSurgical Inc.","product_owner_address":"95 Corporate Drive, Trumbull Connecticut, 06611, United States","registrant_name":"COOPERSURGICAL ORIGIO PTE. LTD.","registrant_address":"1, TEMASEK AVENUE, #39-01, MILLENIA TOWER, Singapore 039192","importer_name":"NEUVITAL PTE. LTD.","importer_address":"1003, BUKIT MERAH CENTRAL, #02-11, Singapore 159836","model_name":"PICSI Sperm Selection Device","model_identifier":"BCT-PICSI-20"},{"_id":35,"device_name":"Image Review LaserPro Plus","description":"LaserPro Plus 1.3 device is intended to be used by a lay person to assist in hair regrowth and promote hair growth via photobiostimulation in the treatment of Female Androgenetic Alopecia and Male Androgenetic Alopecia in adults aged 18 years and above. Norwood Hamilton classification of IIa to V in males and Ludwig classification of frontal in females, I-4 and for II-1 to II-2.","gmdn_term":"Hair growth laser device","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024X0002","registration_date":"24/10/2025 11:48","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Image Review Concepts Pty Ltd","product_owner_short_name":"Image Review Concepts Pty Ltd","product_owner_address":"Ground Floor, 640 Murray Street, West Perth, WA, Australia","registrant_name":"ASIA ACTUAL PTE. LTD.","registrant_address":"116, CHANGI ROAD, #04-05, WIS@CHANGI, Singapore 419718","importer_name":null,"importer_address":null,"model_name":"Laser Pro Plus","model_identifier":"Laser Pro Plus"},{"_id":36,"device_name":"Surgitools Disposable Skin Retractors","description":"The SurgiTools Disposable Skin Retractors are intended for use in surgical procedures requiring retraction of skin and soft tissue to provide exposure and visualization of the surgical site.\n\nThe device includes a variety of hook configurations and elastic stays designed to maintain consistent retraction while minimizing tissue trauma. It allows the surgeon to maintain a clear operative field and perform procedures with improved efficiency.","gmdn_term":null,"medical_speciality_area":"General & Plastic Surgery","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251024W0001","registration_date":"24/10/2025 11:47","change_notification_approval_date":null,"retention_due_date":"23/10/2026 0:00","product_owner_name":"Surgitools (Shanghai) Medical Instruments Co., Ltd.","product_owner_short_name":"Surgitools (Shanghai) Medical Instruments Co., Ltd.","product_owner_address":"Room 426, Building 1,\nNo.255 Shuangbang Road, Xujing Town, Qingpu District,\n201702 Shanghai\n, China","registrant_name":"EN-LIFE MEDICAL (S) PTE. LTD.","registrant_address":"8, COMMONWEALTH LANE, #04-03C, GRANDE BUILDING, Singapore 149555","importer_name":"EN-LIFE MEDICAL (S) PTE. LTD.","importer_address":"8, COMMONWEALTH LANE, #04-03C, GRANDE BUILDING, Singapore 149555","model_name":"Sharp Hooks, 3mm, Sterile, Single Use\nSharp Hooks, 3mm, Sterile, Single Use\nSharp Hooks, 3mm, Sterile, Single Use\nRetractor, 25.3*11.3cm, Sterile Plastic, Single Use\nSharp Hooks, 5mm, Sterile, Single Use\nSharp Hooks, 5mm, Sterile, Single Use\nSharp Hooks, 5mm, Sterile, Single Use\nRetractor, 22.0*11.3cm, Sterile Plastic, Single Use\nBlunt Hooks, 12mm, Sterile, Single Use\nBlunt Hooks, 12mm, Sterile, Single Use\nBlunt Hooks, 12mm, Sterile, Single Use\nRetractor, 32.5*18.3cm, Sterile Plastic, Single Use\nTwo-Bifurcate Hooks, 12mm, Sterile, Single Use\nTwo-Bifurcate Hooks, 12mm, Sterile, Single Use\nTwo-Bifurcate Hooks, 12mm, Sterile, Single Use\nRetractor, 14.1*14.1cm, Sterile Plastic, Single Use\nRetractor, 18.6*18.3cm, Sterile Plastic, Single Use\nRetractor, 28.3*14.1cm, Sterile Plastic, Single Use\nRetractor, 25.0*25.0cm, Sterile Plastic, Single Use\nRetractor, 18.5*11.7cm, Sterile Plastic, Single Use","model_identifier":"SG1601-H-1\nSG1601-H-2\nSG1601-H-6\nSG1601-R\nSG1602-H-1\nSG1602-H-2\nSG1602-H-6\nSG1602-R\nSG1603-H-1\nSG1603-H-2\nSG1603-H-6\nSG1603-R\nSG1604-H-1\nSG1604-H-2\nSG1604-H-4\nSG1604-R\nSG1605-R\nSG1606-R\nSG1607-R\nSG1608-R"},{"_id":37,"device_name":"OXYGEN CONCENTRATOR OLV-5S / OLV-10S","description":"The oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method. The maximum altitude the subject device can operate without degradation of concentration is 2000m.","gmdn_term":null,"medical_speciality_area":"Anaesthesiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251022U0001","registration_date":"22/10/2025 19:01","change_notification_approval_date":null,"retention_due_date":"21/10/2026 0:00","product_owner_name":"Zhengzhou Olive Electronic Technology Co.,Ltd","product_owner_short_name":"Zhengzhou Olive Electronic Technology Co.,Ltd","product_owner_address":"5th Floor, Block D, Building 18, Henan International University, Science Park (East District), 450001 Zhengzhou, Henan, China, China","registrant_name":"AGIS MEDICAL SUPPLIES PTE. LTD.","registrant_address":"50, KALLANG PUDDING ROAD, #08-08, AMA BUILDING, Singapore 349326","importer_name":null,"importer_address":null,"model_name":"OLV-10S\nOLV-5S","model_identifier":"?\n?"},{"_id":38,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM HERA Z30","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021W0013","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"HERA Z30","model_identifier":"HERA Z30"},{"_id":39,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM Z20e","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.\n\n","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021V0012","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"HERA Z20e","model_identifier":"HER Z20e"},{"_id":40,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM RS85","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021U0011","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"RS85","model_identifier":"RS85"},{"_id":41,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM HERA W10","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021T0010","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"HERA W10","model_identifier":"HERA W10"},{"_id":42,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM HM70 EVO","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021B0009","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"HM70 EVO","model_identifier":"HM70 EVO"},{"_id":43,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM R20","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.\n","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021A0008","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"R20","model_identifier":"R20"},{"_id":44,"device_name":" SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM HERA W9","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021Z0007","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"HERA W9","model_identifier":"HERA W9"},{"_id":45,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM HERA Z20","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021Y0006","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"HERA Z20","model_identifier":"HERA Z20"},{"_id":46,"device_name":"SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM R30","description":"The ultrasound scanner and probes are designed to obtain ultrasound images and analyze body fluids.\n","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021X0005","registration_date":"21/10/2025 18:27","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"SAMSUNG MEDISON CO., LTD","product_owner_short_name":"SAMSUNG MEDISON CO., LTD","product_owner_address":"3366, HANSEO-RO, HONGCHEON-GUN, GANGWONDO 25108, KOREA, Korea, South","registrant_name":"SCANMED TECHNOLOGY (S) PTE LTD","registrant_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","importer_name":"SCANMED TECHNOLOGY (S) PTE LTD","importer_address":"192, PANDAN LOOP, #07-22, PANTECH BUSINESS HUB, Singapore 128381","model_name":"R30","model_identifier":"R30"},{"_id":47,"device_name":"Kerr Endodontics K3™ Files","description":"used for root canal shaping and cleaning during endodontic treatment","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021W0004","registration_date":"21/10/2025 17:33","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"Kerr Italia S.r.l.","product_owner_short_name":"Kerr Italia S.r.l.","product_owner_address":"Via Passanti, 174,\nScafati (SA),\n84018,\nItaly, Italy","registrant_name":"EHC COMMERCIAL SINGAPORE PTE. LTD.","registrant_address":"13, STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905","importer_name":"EHC COMMERCIAL SINGAPORE PTE. LTD.","importer_address":"13, STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905","model_name":"K3 ROTARY FILES .02 21MM ASSORTED PK\nK3 ROTARY FILES .02 25MM ASSORTED PK\nK3 ROTARY FILES .15/.02 30MM\nK3 ROTARY FILES .15/.02 21MM\nK3 ROTARY FILES .15/.02 25MM\nK3 ROTARY FILES .20/.02 30MM\nK3 ROTARY FILES .20/.02 21MM\nK3 ROTARY FILES .20/.02 25MM\nK3 ROTARY FILES .25/.02 30MM\nK3 ROTARY FILES .25/.02 21MM\nK3 ROTARY FILES .25/.02 25MM\nK3 ROTARY FILES .30/.02 30MM\nK3 ROTARY FILES .30/.02 21MM\nK3 ROTARY FILES .30/.02 25MM\nK3 ROTARY FILES .35/.02 30MM\nK3 ROTARY FILES .35/.02 21MM\nK3 ROTARY FILES .35/.02 25MM\nK3 ROTARY FILES .40/.02 30MM\nK3 ROTARY FILES .40/.02 21MM\nK3 ROTARY FILES .40/.02 25MM\nK3 ROTARY FILES .45/.02 30MM\nK3 ROTARY FILES .45/.02 21MM\nK3 ROTARY FILES .45/.02 25MM\nK3 ROTARY FILES .04 21MM ASSORTED PK\nK3 ROTARY FILES .04 25MM ASSORTED PK\nK3 ROTARY FILES .15/.04 30MM\nK3 ROTARY FILES .15/.04 21MM\nK3 ROTARY FILES .15/.04 25MM\nK3 ROTARY FILES .20/.04 30MM\nK3 ROTARY FILES .20/.04 21MM\nK3 ROTARY FILES .20/.04 25MM\nK3 ROTARY FILES .25/.04 30MM\nK3 ROTARY FILES .25/.04 21MM\nK3 ROTARY FILES .25/.04 25MM\nK3 ROTARY FILES .30/.04 30MM\nK3 ROTARY FILES .30/.04 21MM\nK3 ROTARY FILES .30/.04 25MM\nK3 ROTARY FILES .35/.04 30MM\nK3 ROTARY FILES .35/.04 21MM\nK3 ROTARY FILES .35/.04 25MM\nK3 ROTARY FILES .40/.04 30MM\nK3 ROTARY FILES .40/.04 21MM\nK3 ROTARY FILES .40/.04 25MM\nK3 ROTARY FILES .45/.04 30MM\nK3 ROTARY FILES .45/.04 21MM\nK3 ROTARY FILES .45/.04 25MM\nK3 ROTARY FILES .50/.04 30MM\nK3 ROTARY FILES .50/.04 21MM\nK3 ROTARY FILES .50/.04 25MM\nK3 ROTARY FILES .55/.04 30MM\nK3 ROTARY FILES .55/.04 21MM\nK3 ROTARY FILES .55/.04 25MM\nK3 ROTARY FILES .60/.04 30MM\nK3 ROTARY FILES .60/.04 21MM\nK3 ROTARY FILES .60/.04 25MM\nK3 ROTARY FILES .06 21MM ASSORTED PK\nK3 ROTARY FILES .06 25MM ASSORTED PK\nK3 ROTARY FILES .15/.06 30MM\nK3 ROTARY FILES .15/.06 21MM\nK3 ROTARY FILES .15/.06 25MM\nK3 ROTARY FILES .20/.06 30MM\nK3 ROTARY FILES .20/.06 21MM\nK3 ROTARY FILES .20/.06 25MM\nK3 ROTARY FILES .25/.06 30MM\nK3 ROTARY FILES .25/.06 21MM\nK3 ROTARY FILES .25/.06 25MM\nK3 ROTARY FILES .30/.06 30MM\nK3 ROTARY FILES .30/.06 21MM\nK3 ROTARY FILES .30/.06 25MM\nK3 ROTARY FILES .35/.06 30MM\nK3 ROTARY FILES .35/.06 21MM\nK3 ROTARY FILES .35/.06 25MM\nK3 ROTARY FILES .40/.06 30MM\nK3 ROTARY FILES .40/.06 21MM\nK3 ROTARY FILES .40/.06 25MM\nK3 ROTARY FILES .45/.06 30MM\nK3 ROTARY FILES .45/.06 21MM\nK3 ROTARY FILES .45/.06 25MM\nK3 ROTARY FILES .50/.06 30MM\nK3 ROTARY FILES .50/.06 21MM\nK3 ROTARY FILES .50/.06 25MM\nK3 ROTARY FILES .55/.06 30MM\nK3 ROTARY FILES .55/.06 21MM\nK3 ROTARY FILES .55/.06 25MM\nK3 ROTARY FILES .60/.06 30MM\nK3 ROTARY FILES .60/.06 21MM\nK3 ROTARY FILES .60/.06 25MM\nK3 ROTARY FILES .25/.10 21MM\nK3 ROTARY FILES .25/.10 25MM\nK3 ROTARY FILES .25/.10 17MM\nK3 ROTARY FILES .04 21MM ASSORTED PK\nK3 ROTARY FILES .04 25MM ASSORTED PK\nK3 ROTARY FILES .06 21MM ASSORTED PK\nK3 ROTARY FILES .06 25MM ASSORTED PK\nK3 ROTARY FILES .25/.12 21MM\nK3 ROTARY FILES .25/.12 25MM\nK3 ROTARY FILES .25/.12 17MM\nK3 ROTARY FILES VTVT 21MM ASSORTED PK\nK3 ROTARY FILES VTVT 25MM ASSORTED PK\nK3 ROTARY FILES .25/.08 21MM\nK3 ROTARY FILES .25/.08 25MM\nK3 ROTARY FILES .25/.08 17MM\nK3 ROTARY FILES, G-PACK, 21MM\nK3 ROTARY FILES, G-PACK, 25MM","model_identifier":"825-2021\n825-2025\n825-2150\n825-2151\n825-2155\n825-2200\n825-2201\n825-2205\n825-2250\n825-2251\n825-2255\n825-2300\n825-2301\n825-2305\n825-2350\n825-2351\n825-2355\n825-2400\n825-2401\n825-2405\n825-2450\n825-2451\n825-2455\n825-4021\n825-4025\n825-4150\n825-4151\n825-4155\n825-4200\n825-4201\n825-4205\n825-4250\n825-4251\n825-4255\n825-4300\n825-4301\n825-4305\n825-4350\n825-4351\n825-4355\n825-4400\n825-4401\n825-4405\n825-4450\n825-4451\n825-4455\n825-4500\n825-4501\n825-4505\n825-4550\n825-4551\n825-4555\n825-4600\n825-4601\n825-4605\n825-6021\n825-6025\n825-6150\n825-6151\n825-6155\n825-6200\n825-6201\n825-6205\n825-6250\n825-6251\n825-6255\n825-6300\n825-6301\n825-6305\n825-6350\n825-6351\n825-6355\n825-6400\n825-6401\n825-6405\n825-6450\n825-6451\n825-6455\n825-6500\n825-6501\n825-6505\n825-6550\n825-6551\n825-6555\n825-6600\n825-6601\n825-6605\n830-0251\n830-0255\n830-0257\n830-0421\n830-0425\n830-0621\n830-0625\n830-2251\n830-2255\n830-2257\n830-7721\n830-7725\n830-8251\n830-8255\n830-8257\n830-9921\n830-9925"},{"_id":48,"device_name":"MAKO 4 ROBOTIC ARM","description":"The Mako System is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.\nThe Mako System is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy.\nThese procedures include unicondylar knee replacement and/or patellofemoral replacement (PKA); Total Knee Arthroplasty (TKA); and Total Hip Arthroplasty (THA).","gmdn_term":null,"medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021V0003","registration_date":"21/10/2025 12:38","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"Mako Surgical Corp.","product_owner_short_name":"Mako Surgical Corp.","product_owner_address":"3365 Enterprise Avenue, Weston, Florida, 33331, United States","registrant_name":"STRYKER SINGAPORE PRIVATE LIMITED","registrant_address":"38, BEACH ROAD, #23-11, SOUTH BEACH TOWER, Singapore 189767","importer_name":null,"importer_address":null,"model_name":"MAKO 4 ROBOTIC ARM","model_identifier":"229999"},{"_id":49,"device_name":"Unitron Moxi S-R","description":"Hearing Aid - The hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing.\n\nTinnitus Feature - The Tinnitus feature is intended for use by people with tinnitus who also desire amplification. It provides supplementary\nnoise stimulation which can help defocus the user`s attention from their tinnitus.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021U0002","registration_date":"21/10/2025 11:53","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"Sonova AG","product_owner_short_name":"Sonova AG","product_owner_address":"Laubisrutistrasse 28, CH-8712 Stafa, Switzerland","registrant_name":"SONOVA SINGAPORE PTE. LTD.","registrant_address":"21, MEDIA CIRCLE, #07-01/04, INFINITE STUDIOS, Singapore 138562","importer_name":"SONOVA SINGAPORE PTE. LTD.","importer_address":"21, MEDIA CIRCLE, #07-01/04, INFINITE STUDIOS, Singapore 138562","model_name":"Unitron Moxi S1-R\nUnitron Moxi S1-R\nUnitron Moxi S1-R\nUnitron Moxi S1-R\nUnitron Moxi S3-R\nUnitron Moxi S3-R\nUnitron Moxi S3-R\nUnitron Moxi S3-R\nUnitron Moxi S3-R\nUnitron Moxi S3-R\nUnitron Moxi S5-R\nUnitron Moxi S5-R\nUnitron Moxi S5-R\nUnitron Moxi S5-R\nUnitron Moxi S5-R\nUnitron Moxi S5-R\nUnitron Moxi S7-R\nUnitron Moxi S7-R\nUnitron Moxi S7-R\nUnitron Moxi S7-R\nUnitron Moxi S7-R\nUnitron Moxi S7-R\nUnitron Moxi S9-R\nUnitron Moxi S9-R\nUnitron Moxi S9-R\nUnitron Moxi S9-R\nUnitron Moxi S9-R\nUnitron Moxi S9-R\nUnitron Moxi S-R FLEX:TRIAL\nUnitron Remote Plus\nUnitron TrueFit","model_identifier":"050-6910-P2\n050-6910-P6\n050-6910-P7\n050-6910-R8\n050-6911-P2\n050-6911-P4\n050-6911-P6\n050-6911-P7\n050-6911-P8\n050-6911-R8\n050-6912-P2\n050-6912-P4\n050-6912-P6\n050-6912-P7\n050-6912-P8\n050-6912-R8\n050-6913-P2\n050-6913-P4\n050-6913-P6\n050-6913-P7\n050-6913-P8\n050-6913-R8\n050-6914-P2\n050-6914-P4\n050-6914-P6\n050-6914-P7\n050-6914-P8\n050-6914-R8\n050-6915-P6\n088-5016\n088-5019-00057"},{"_id":50,"device_name":"Remel BactiStaph ","description":"Remel BactiStaph kit is a rapid slide latex agglutination test recommended for use in qualitative procedures for the detection of both clumping factor and protein A which are used to distinguish Staphylococcus aureus from other species of staphylococci. This test is for use with colonies from primary cultures suspected of being S. aureus.","gmdn_term":null,"medical_speciality_area":"Microbiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251021T0001","registration_date":"21/10/2025 8:52","change_notification_approval_date":null,"retention_due_date":"20/10/2026 0:00","product_owner_name":"Thermo Scientific Microbiology Pte Ltd","product_owner_short_name":"Thermo Scientific Microbiology Pte Ltd","product_owner_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","registrant_name":"THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.","registrant_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","importer_name":"THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.","importer_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","model_name":"BactiStaph\nBactiStaph","model_identifier":"R21143\nR21144"},{"_id":51,"device_name":"Zimmer Cryo 7","description":"Cryo 7 is a cryotherapy (cold air therapy) device intended to cool the patient’s skin locally and contactless. The scope of application extends to the physical therapy for pain and inflammation processes of the musculoskeletal system as well as to the treatment of varicose veins. In addition, it provides a supportive cooling method for pain reduction during and after dermatological treatments, during and after the application of laser, IPL and other such equipment for skin resurfacing, tattoo or hair removal or other skin treatment, or while giving injections.","gmdn_term":"Localized cutaneous/musculoskeletal cryotherapy unit","medical_speciality_area":"General & Plastic Surgery","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251017C0005","registration_date":"17/10/2025 19:33","change_notification_approval_date":null,"retention_due_date":"16/10/2026 0:00","product_owner_name":"Zimmer MedizinSysteme GmbH","product_owner_short_name":"Zimmer MedizinSysteme GmbH","product_owner_address":"JunkersstraBe 9, 89231 Neu-Ulm, Germany","registrant_name":"VANGUARD AESTHETICS PTE. LTD.","registrant_address":"19, KIM KEAT ROAD, #06-01, FU TSU BUILDING, Singapore 328804","importer_name":"VANGUARD AESTHETICS PTE. LTD.","importer_address":"19, KIM KEAT ROAD, #06-01, FU TSU BUILDING, Singapore 328804","model_name":"Cryo 7\nCryo 7","model_identifier":"7350\n7360"},{"_id":52,"device_name":"Shofu Dental Cement","description":"Compounds used to bond a dental prosthesis to the anatomy (luting agent), to form an insulating layer under dental restorations. It may include accessories to complete the cementing procedure\n","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251017B0004","registration_date":"17/10/2025 16:46","change_notification_approval_date":null,"retention_due_date":"16/10/2026 0:00","product_owner_name":"Shofu Inc","product_owner_short_name":"Shofu Inc","product_owner_address":"11 Kamitakamatsu-cho Fukuine, Higashiyama-ku Kyoto 605-0983, Japan","registrant_name":"SHOFU DENTAL ASIA-PACIFIC PTE. LTD.","registrant_address":"1, SCIENCE PARK ROAD, #01-01, THE CAPRICORN, Singapore 117528","importer_name":"SHOFU DENTAL ASIA-PACIFIC PTE. LTD.","importer_address":"1, SCIENCE PARK ROAD, #01-01, THE CAPRICORN, Singapore 117528","model_name":"BeautiLink SA Handmix syringe 9mL (15.6g) Clear 1pc\nBeautiLink SA Handmix syringe 9mL (15.6g) Ivory 1pc\nBeautiLink SA Handmix syringe 9mL (15.6g) Opaque 1pc\nBeautiLink SA Automix syringe 5mL (8.6g) Clear 1pc\nBeautiLink SA Automix syringe 5mL (8.6g) Ivory 1pc\nBeautiLink SA Automix syringe 5mL (8.6g) Opaque 1pc\nBeautiLink SA Automix syringe 2.5mL (4.4g) Clear 1pc (SAMPLE)\nBeautiLink SA Automix syringe 2.5mL (4.4g) Ivory 1pc (SAMPLE)\nBeautiLink SA Automix syringe 2.5mL (4.4g) Opaque 1pc (SAMPLE\nBeautiLink SA Handmix syringe 9mL (15.6g) Clear 2pcs\nBeautiLink SA Handmix syringe 9mL (15.6g) Ivory 2pcs\nBeautiLink SA Handmix syringe 9mL (15.6g) Opaque 2pcs\nBeautiLink SA Automix syringe 5mL (8.6g) Clear 2pcs\nBeautiLink SA Automix syringe 5mL (8.6g) Ivory 2pcs\nBeautiLink SA Automix syringe 5mL (8.6g) Opaque 2pcs","model_identifier":"C0200\nC0201\nC0202\nC0203\nC0204\nC0205\nC0206\nC0207\nC0208\nC0209\nC0210\nC0211\nC0212\nC0213\nC0214"},{"_id":53,"device_name":"Angiogram Set, Angiogram Set, Angioplasty Set ","description":"A Collection of medical devices and materials intended to be used in a general and clinical surgical procedure","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251017A0003","registration_date":"17/10/2025 16:32","change_notification_approval_date":null,"retention_due_date":"16/10/2026 0:00","product_owner_name":"PPM Medical Singapore Pte Ltd","product_owner_short_name":"PPM Medical Singapore Pte Ltd","product_owner_address":"2, BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554","registrant_name":"PPM MEDICAL PTE. LTD.","registrant_address":"2, BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554","importer_name":"PPM MEDICAL PTE. LTD.","importer_address":"2, BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554","model_name":"Angiogram Set, Angiogram Set, Angioplasty Set","model_identifier":"10-075, 10-077, 10-079"},{"_id":54,"device_name":"Sciton mJoule","description":"The mJoule with 1064 Nd:YAG is designed for use in coagulation and hemostasis of acne, treatment for the temporary increase of clear nail in patients with onychomycosis and treatment of periungual, subungual warts, and plantar warts. mJOULE 1927nm Laser System is indicated for use in the coagulation of soft tissue and treatment of actinic keratosis. The BBL system is designed for use in treatment of mild to moderate inflammatory and pustular inflammatory acne vulgaris.","gmdn_term":"Multi-modality skin surface treatment system","medical_speciality_area":"General & Plastic Surgery","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251017Z0002","registration_date":"17/10/2025 15:38","change_notification_approval_date":null,"retention_due_date":"16/10/2026 0:00","product_owner_name":"Sciton, Inc.","product_owner_short_name":"Sciton, Inc.","product_owner_address":"925 Commercial Street, Palo Alto, CA 94303, United States","registrant_name":"SERVICOM MEDICAL (SINGAPORE) PTE LTD","registrant_address":"140, PAYA LEBAR ROAD, #06-03, AZ @ PAYA LEBAR, Singapore 409015","importer_name":"SERVICOM MEDICAL (SINGAPORE) PTE LTD","importer_address":"140, PAYA LEBAR ROAD, #06-03, AZ @ PAYA LEBAR, Singapore 409015","model_name":"mJoule with BBL & Moxi\nmJoule with Moxi\nmJoule with BBL\nmJoule with ClearV/ClearSilk\nmJoule with BBL & ClearV/ClearSilk\nBBL Handpiece\nBBl HEROic Handpiece\nClearSilk Handpiece\nMoxi Handpiece\nClearV Handpiece","model_identifier":"1500-020-70\n1500-021-70\n1500-022-70\n1500-024-70\n1500-025-70\n1500-202-81\n1500-204-80\n1500-219-00\n1500-294-00\n1500-302-00"},{"_id":55,"device_name":"InstaFill Graft Delivery System","description":"The InstaFill Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. ","gmdn_term":null,"medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251017Y0001","registration_date":"17/10/2025 11:45","change_notification_approval_date":null,"retention_due_date":"16/10/2026 0:00","product_owner_name":"GLOBUS MEDICAL INC","product_owner_short_name":"GLOBUS MEDICAL INC","product_owner_address":"Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA 19403, United States","registrant_name":"Globus Medical Singapore PTE. LTD.","registrant_address":"137, Telok Ayer Street, #08-01, Singapore 068602","importer_name":null,"importer_address":null,"model_name":"InstaFill Conical Tip\nInstaFill Cartridge, 5cc","model_identifier":"6132.5003S\n6132.6005S"},{"_id":56,"device_name":"Zimmer Alliance Glenoid System","description":"The Alliance Glenoid system is designed to replace the articulation surface of the glenoid. It is indicated for: \n1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. \n2. Rheumatoid arthritis. \n3. Correction of functional deformity. \n4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. \n5. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. \nThe Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.","gmdn_term":"Total shoulder prosthesis","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251016C0006","registration_date":"16/10/2025 20:43","change_notification_approval_date":null,"retention_due_date":"15/10/2026 0:00","product_owner_name":"Zimmer Inc","product_owner_short_name":"Zimmer Inc","product_owner_address":"1800 West Centre Street, Warsaw IN 46580, United States","registrant_name":"ZIMMER PTE. LTD.","registrant_address":"401, COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598","importer_name":"ZIMMER PTE. LTD.","importer_address":"401, COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598","model_name":"Alliance Glenoid Monoblock 2 Peg Size 1\nAlliance Glenoid Monoblock 2 Peg Size 2\nAlliance Glenoid Monoblock 2 Peg Size 3\nAlliance Glenoid Monoblock 2 Peg Size 4\nAlliance Glenoid Monoblock 2 Peg Size 5\nAlliance Glenoid Monoblock 3 Peg Size 1\nAlliance Glenoid Monoblock 3 Peg Size 2\nAlliance Glenoid Monoblock 3 Peg Size 3\nAlliance Glenoid Monoblock 3 Peg Size 4\nAlliance Glenoid Monoblock 3 Peg Size 5\nAlliance Glenoid Modular 3 Peg Size 1\nAlliance Glenoid Modular 3 Peg Size 2\nAlliance Glenoid Modular 3 Peg Size 3\nAlliance Glenoid Modular 3 Peg Size 4\nAlliance Glenoid Modular 3 Peg Size 5\nAlliance Glenoid Modular 4 Peg Size 2\nAlliance Glenoid Modular 4 Peg Size 3\nAlliance Glenoid Modular 4 Peg Size 4\nAlliance Glenoid Modular 4 Peg Size 5\nAlliance Glenoid Modular Augment 4 Peg Left Size 2\nAlliance Glenoid Modular Augment 4 Peg Left Size 3\nAlliance Glenoid Modular Augment 4 Peg Left Size 4\nAlliance Glenoid Modular Augment 4 Peg Left Size 5\nAlliance Glenoid Modular Augment 4 Peg Right Size 2\nAlliance Glenoid Modular Augment 4 Peg Right Size 3\nAlliance Glenoid Modular Augment 4 Peg Right Size 4\nAlliance Glenoid Modular Augment 4 Peg Right Size 5\nAlliance Glenoid Modular Post Plasma Spray\nAlliance Glenoid Trabecular Metal Modular Post Tantulum\nAlliance Glenoid Monoblock Trial 2 Peg Size 1 (Nonsterile)\nAlliance Glenoid Monoblock Trial 2 Peg Size 2 (Nonsterile)\nAlliance Glenoid Monoblock Trial 2 Peg Size 3 (Nonsterile)\nAlliance Glenoid Monoblock Trial 2 Peg Size 4 (Nonsterile)\nAlliance Glenoid Monoblock Trial 2 Peg Size 5 (Nonsterile)\nAlliance Glenoid Monoblock Trial 3 Peg Size 1 (Nonsterile)\nAlliance Glenoid Monoblock Trial 3 Peg Size 2 (Nonsterile)\nAlliance Glenoid Monoblock Trial 3 Peg Size 3 (Nonsterile)\nAlliance Glenoid Monoblock Trial 3 Peg Size 4 (Nonsterile)\nAlliance Glenoid Monoblock Trial 3 Peg Size 5 (Nonsterile)\nAlliance Glenoid Modular Trial 3 Peg Size 1 (Nonsterile)\nAlliance Glenoid Modular Trial 3 Peg Size 2 (Nonsterile)\nAlliance Glenoid Modular Trial 3 Peg Size 3 (Nonsterile)\nAlliance Glenoid Modular Trial 3 Peg Size 4 (Nonsterile)\nAlliance Glenoid Modular Trial 3 Peg Size 5 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Left Size 2 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Left Size 3 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Left Size 4 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Left Size 5 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Right Size 2 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Right Size 3 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Right Size 4 (Nonsterile)\nAlliance Glenoid Modular Trial Augment 4 Peg Right Size 5 (Nonsterile)\nAlliance Glenoid Augment Reamer Guide 4 Peg Left\nAlliance Glenoid Augment Reamer Guide 4 Peg Right","model_identifier":"SAGL2011\nSAGL2012\nSAGL2013\nSAGL2014\nSAGL2015\nSAGL2021\nSAGL2022\nSAGL2023\nSAGL2024\nSAGL2025\nSAGL2031\nSAGL2032\nSAGL2033\nSAGL2034\nSAGL2035\nSAGL2042\nSAGL2043\nSAGL2044\nSAGL2045\nSAGL2142\nSAGL2143\nSAGL2144\nSAGL2145\nSAGL2242\nSAGL2243\nSAGL2244\nSAGL2245\nSAGP0001\nSAGP0002\nSBGL6011\nSBGL6012\nSBGL6013\nSBGL6014\nSBGL6015\nSBGL6021\nSBGL6022\nSBGL6023\nSBGL6024\nSBGL6025\nSBGL6031\nSBGL6032\nSBGL6033\nSBGL6034\nSBGL6035\nSBGL6142\nSBGL6143\nSBGL6144\nSBGL6145\nSBGL6242\nSBGL6243\nSBGL6244\nSBGL6245\nSBGL7009\nSBGL7010"},{"_id":57,"device_name":"GN ReSound Enzon IA Hearing Aids (BTE, WIRELESS, DIGITAL)","description":"The hearing aid is intended to compensate for hearing impairment by amplifying and transmitting sound to the ear. It also includes a Tinnitus Management Program to temporarily relieve patients suffering from Tinnitus for adults over 18 years of age and also suitable for children over 12 years of age and older.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251016B0005","registration_date":"16/10/2025 17:43","change_notification_approval_date":null,"retention_due_date":"15/10/2026 0:00","product_owner_name":"GN Hearing A/S","product_owner_short_name":"GN Hearing A/S","product_owner_address":"Lautrupbjerg 7, DK-2750 Ballerup, Denmark","registrant_name":"GN HEARING PTE. LTD.","registrant_address":"3, IRVING ROAD, #05-08, TAI SENG CENTRE, Singapore 369522","importer_name":"GN HEARING PTE. LTD.","importer_address":"67, UBI CRESCENT, #04-09, TECHNIQUES CENTRE, Singapore 408560","model_name":"APP,RS SMART 3D,1.41,IOS\nAPP,RS SMART 3D,1.41,ANDR\nAPP,RS SMART,4.37,IOS\nAPP,RS SMART,4.37,ANDR\nHI,EI998-DWHC,BTE,GLD\nHI,EI998-DWHC,BTE,WRM GRY\nHI,EI998-DWHC,BTE,ESP\nHI,EI998-DWHC,BTE,DP BLK\nHI,EI998-DWHC,BTE,BRNZ\nHI,EI998-DWHC,BTE,SAND\nHI,EI998-DWHC,BTE,SPK SIL\nHI,EI998-DWHC,BTE,GRPH\nHI,EI998-DWHC,BTE,RED\nHI,EI998-DWHC,BTE,NV BLU\nHI,EI798-DWHC,BTE,GLD\nHI,EI798-DWHC,BTE,WRM GRY\nHI,EI798-DWHC,BTE,ESP\nHI,EI798-DWHC,BTE,DP BLK\nHI,EI798-DWHC,BTE,BRNZ\nHI,EI798-DWHC,BTE,SAND\nHI,EI798-DWHC,BTE,SPK SIL\nHI,EI798-DWHC,BTE,GRPH\nHI,EI798-DWHC,BTE,RED\nHI,EI798-DWHC,BTE,NV BLU\nHI,EI598-DWHC,BTE,GLD\nHI,EI598-DWHC,BTE,WRM GRY\nHI,EI598-DWHC,BTE,ESP\nHI,EI598-DWHC,BTE,DP BLK\nHI,EI598-DWHC,BTE,BRNZ\nHI,EI598-DWHC,BTE,SAND\nHI,EI598-DWHC,BTE,SPK SIL\nHI,EI598-DWHC,BTE,GRPH\nHI,EI598-DWHC,BTE,RED\nHI,EI598-DWHC,BTE,NV BLU\nHI,EI498-DWHC,BTE,GLD\nHI,EI498-DWHC,BTE,WRM GRY\nHI,EI498-DWHC,BTE,ESP\nHI,EI498-DWHC,BTE,DP BLK\nHI,EI498-DWHC,BTE,BRNZ\nHI,EI498-DWHC,BTE,SAND\nHI,EI498-DWHC,BTE,SPK SIL\nHI,EI498-DWHC,BTE,GRPH\nHI,EI498-DWHC,BTE,RED\nHI,EI498-DWHC,BTE,NV BLU\nHI,EI398-DWHC,BTE,GLD\nHI,EI398-DWHC,BTE,WRM GRY\nHI,EI398-DWHC,BTE,ESP\nHI,EI398-DWHC,BTE,DP BLK\nHI,EI398-DWHC,BTE,BRNZ\nHI,EI398-DWHC,BTE,SAND\nHI,EI398-DWHC,BTE,SPK SIL\nHI,EI398-DWHC,BTE,GRPH\nHI,EI398-DWHC,BTE,RED\nHI,EI398-DWHC,BTE,NV BLU\nHI,EIX98-DWHC,BTE,FDEMO,SAND\nSW,FSW CS SMART FIT 2.2,UP1","model_identifier":"20410600\n20410700\n20993200\n20993300\n22445570\n22445571\n22445572\n22445573\n22445574\n22445575\n22445576\n22445577\n22445578\n22445579\n23369270\n23369271\n23369272\n23369273\n23369274\n23369275\n23369276\n23369277\n23369278\n23369279\n23369370\n23369371\n23369372\n23369373\n23369374\n23369375\n23369376\n23369377\n23369378\n23369379\n23369470\n23369471\n23369472\n23369473\n23369474\n23369475\n23369476\n23369477\n23369478\n23369479\n23597370\n23597371\n23597372\n23597373\n23597374\n23597375\n23597376\n23597377\n23597378\n23597379\n23613475\n23838000"},{"_id":58,"device_name":"Zhangjiagang Shengang Enteral Feeding Bag(Pump type)","description":"Enteral Feeding Bag (Pump) is used with a nasal feeding tube or a stomach tube and connected with nutrition pump for clinical enteral nutrition input.","gmdn_term":null,"medical_speciality_area":"Gastroenterology & Urology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251016A0004","registration_date":"16/10/2025 16:55","change_notification_approval_date":null,"retention_due_date":"15/10/2026 0:00","product_owner_name":"Zhangjiagang Shengang Medical Products Co., Ltd","product_owner_short_name":"Zhangjiagang Shengang Medical Products Co., Ltd","product_owner_address":"No. 388, Yongjin Road, Tangqiao Town, 215615, Zhangjiagang City, Jiangsu Province, China","registrant_name":"NUTRI-TECH (S) PTE. LTD.","registrant_address":"13, LORONG 8 TOA PAYOH, #05-07, BRADDELL TECH, Singapore 319261","importer_name":"NUTRI-TECH (S) PTE. LTD.","importer_address":"65A, JALAN TENTERAM, #07-07, ST. MICHAEL'S ESTATE FLATTED FACTORY, Singapore 328958","model_name":"Enteral Feeding Bag(Pump type)\nEnteral Feeding Bag(Pump type)\nEnteral Feeding Bag(Pump type)","model_identifier":"EFP-I-1000\nEFP-I-1500\nEFP-I-500"},{"_id":59,"device_name":"Zimmer MedizinSysteme SonoOne","description":"Ultrasound therapy produces high-frequency electrical signals. Ultrasound wave accordingly generated by transducers will permeate the surface layer of tissue, generating heat effect, mechanic effect and chemical effect to achieve treatment purpose.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251016Z0003","registration_date":"16/10/2025 10:01","change_notification_approval_date":null,"retention_due_date":"15/10/2026 0:00","product_owner_name":"Zimmer MedizinSysteme GmbH","product_owner_short_name":"Zimmer MedizinSysteme GmbH","product_owner_address":"Junkersstr. 9\n89231 Neu-Ulm\nGERMANY, Germany","registrant_name":"HUMANA MEDICAL PTE. LIMITED","registrant_address":"51, GOLDHILL PLAZA, #07-07, Singapore 308900","importer_name":"HUMANA MEDICAL PTE. LIMITED","importer_address":"51, GOLDHILL PLAZA, #07-07, Singapore 308900","model_name":"Only applies to SonoOne\nSonoOne\nn/a\nn/a","model_identifier":"4201\n5360\n53601100\n53601110"},{"_id":60,"device_name":"KCI Solventum V.A.C.® Peel and Place Dressing Kit","description":"The V.A.C.® Peel and Place Dressing is intended to be applied in an acute, extended,\nor home care setting where product application is conducted by or under the supervision of\na qualified healthcare professional.\nWhen used on open wounds, the V.A.C.® Peel and Place Dressing Kit with the V.A.C.®\nTherapy System is intended to create an environment that promotes wound healing by\nsecondary or tertiary (delayed primary) intention by preparing the wound bed for closure,\nreducing edema, promoting granulation tissue formation and perfusion, and by removing\nexudate and infectious material. Open wound types are: acute and subacute dehisced\nwounds, traumatic wounds, partial-thickness burns, flaps, grafts and chronic diabetic ulcers,\npressure ulcers and venous insufficiency ulcers.","gmdn_term":"Negative-pressure wound therapy system foam dressing, non-antimicrobial","medical_speciality_area":"General & Plastic Surgery","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251016Y0002","registration_date":"16/10/2025 8:03","change_notification_approval_date":null,"retention_due_date":"15/10/2026 0:00","product_owner_name":"KCI USA, Inc.","product_owner_short_name":"KCI USA, Inc.","product_owner_address":"12930 IH 10 West, San Antonio, Texas 78249, United States","registrant_name":"KCI MEDICAL ASIA PTE. LTD.","registrant_address":"10, ANG MO KIO STREET 65, #01-01, TECHPOINT, Singapore 569059","importer_name":"KCI MEDICAL ASIA PTE. LTD.","importer_address":"10, ANG MO KIO STREET 65, #01-01, TECHPOINT, Singapore 569059","model_name":"Solventum V.A.C.® Peel and Place Dressing Kit, Large\nSolventum V.A.C.® Peel and Place Dressing Kit, Medium\nSolventum V.A.C.® Peel and Place Dressing Kit, Small","model_identifier":"EZ5LRG\nEZ5MED\nEZ5SML"},{"_id":61,"device_name":"Philips CT 5300 CT Scanner System","description":"The Philips CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Philips CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.","gmdn_term":"Full-body CT system","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251016X0001","registration_date":"16/10/2025 8:02","change_notification_approval_date":null,"retention_due_date":"15/10/2026 0:00","product_owner_name":"Philips Healthcare (Suzhou) Co., Ltd.","product_owner_short_name":"Philips Healthcare (Suzhou) Co., Ltd.","product_owner_address":"No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024 Suzhou, Jiangsu Province, China","registrant_name":"PHILIPS ELECTRONICS SINGAPORE PTE LTD","registrant_address":"622, LORONG 1 TOA PAYOH, #-, Singapore 319763","importer_name":"PHILIPS ELECTRONICS SINGAPORE PTE LTD","importer_address":"622, LORONG 1 TOA PAYOH, #L3-NA, Singapore 319763","model_name":"CT 5300\nIncisive CT and CT 5300 Upgrades","model_identifier":"728285\n728286"},{"_id":62,"device_name":"Remel Staphaurex Plus ","description":"Staphaurex™ Plus is a qualitative latex slide agglutination test for the differentiation of Staphylococcus aureus from other Staphylococcus species isolates grown on agar by the detection of clumping factor and Protein A and/or surface antigens specific to Staphylococcus aureus. Used in a diagnostic workflow to aid clinicians in treatment options for patients suspected of having bacterial infections. The device is not automated, is for professional use only and is not a companion diagnostic.\n","gmdn_term":null,"medical_speciality_area":"Microbiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251015B0006","registration_date":"15/10/2025 18:55","change_notification_approval_date":null,"retention_due_date":"14/10/2026 0:00","product_owner_name":"Thermo Scientific Microbiology Pte Ltd","product_owner_short_name":"Thermo Scientific Microbiology Pte Ltd","product_owner_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","registrant_name":"THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.","registrant_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","importer_name":"THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.","importer_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","model_name":"Staphaurex Plus","model_identifier":"R30950102"},{"_id":63,"device_name":"Sentinel SENTiFIT® 800 Analyzer","description":"The SENTiFIT® 800 Analyzer is an automated analyzer intended for the determination of analytes in human\nspecimen. For the specific purpose refer to the assay’s intended use.\nFor In Vitro Diagnostic use only. For laboratory professional use only.","gmdn_term":null,"medical_speciality_area":"Clinical chemistry","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251015A0005","registration_date":"15/10/2025 15:02","change_notification_approval_date":null,"retention_due_date":"14/10/2026 0:00","product_owner_name":"SENTINEL CH. S.p.A.","product_owner_short_name":"SENTINEL CH. S.p.A.","product_owner_address":"Via Robert Koch, 2, Milano (MI), 20152, Italy","registrant_name":"BIOMED DIAGNOSTICS PTE LTD","registrant_address":"18, BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966","importer_name":null,"importer_address":null,"model_name":"SENTiFIT® 800 Analyzer\nWASH SOLUTION #9\nWASH SOLUTION C-1\nWASH SOLUTION #3","model_identifier":"550802\nSF0007\nSF0010\nSF0011"},{"_id":64,"device_name":"Butterfly Network Butterfly iQ3 Ultrasound System","description":"Indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications:\n• Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies)\n• Procedural Guidance\n• Small Organs (including thyroid, scrotum, and breast)\n• Cardiac\n• Abdominal\n• Urology\n• Fetal/Obstetric\n• Gynecological\n• Musculoskeletal (conventional)\n• Musculoskeletal (superficial)\n• Ophthalmic","gmdn_term":"Hand-held ultrasound imaging system, body-surface","medical_speciality_area":"Radiology / Imaging","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251015Z0004","registration_date":"15/10/2025 13:41","change_notification_approval_date":null,"retention_due_date":"14/10/2026 0:00","product_owner_name":"Butterfly Network, Inc.","product_owner_short_name":"Butterfly Network, Inc.","product_owner_address":"1600 District Ave,, Burlington, MA 01803 USA., United States","registrant_name":"WELLESTA HEALTHCARE (SINGAPORE) PTE. LTD.","registrant_address":"360, ORCHARD ROAD, #11-03A, INTERNATIONAL BUILDING, Singapore 238869","importer_name":"WELLESTA HEALTHCARE (SINGAPORE) PTE. LTD.","importer_address":"360, ORCHARD ROAD, #11-03A, INTERNATIONAL BUILDING, Singapore 238869","model_name":"Butterfly iQ3 Ultrasound System\nButterfly iQ App (Application) Software, v2.40.0","model_identifier":"900-20052-05\n975-20003-00"},{"_id":65,"device_name":"Oxoid E. coli O157 Latex Test ","description":"A qualitative latex slide agglutination test for the confirmatory identification of E. coli serogroup O157 isolates grown on agar. Used in a diagnostic workflow to aid clinicians in treatment options for patients suspected of having bacterial infections. The device is not automated, is for professional use only and is not a companion diagnostic.","gmdn_term":null,"medical_speciality_area":"Microbiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251015Y0003","registration_date":"15/10/2025 12:21","change_notification_approval_date":null,"retention_due_date":"14/10/2026 0:00","product_owner_name":"Thermo Scientific Microbiology Pte Ltd","product_owner_short_name":"Thermo Scientific Microbiology Pte Ltd","product_owner_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","registrant_name":"THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.","registrant_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","importer_name":"THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.","importer_address":"33, MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256","model_name":"E.coli Latex Test","model_identifier":"DR0620M"},{"_id":66,"device_name":"Phoenix ICON GO","description":"The Phoenix ICON GO System, manufactured by Phoenix Technology Group LLC, is intended for general ophthalmic imaging applications, specifically for retinal, corneal, and external structures of the eye. The device is approved for use in both pediatric and adult populations across various age groups:\n\n1. Adults\n\n2. Pediatrics:\n- Neonate/Newborn: Birth through 28 days\n- Infant: From 29 days to 2 years of age\n- Child: From 2 years to 12 years of age\n- Adolescent: From 12 years to 18 years of age\n- Transitional Adolescent A: 18 through 21 years of age\n- Transitional Adolescent B: 18 through 21 years of age.\n","gmdn_term":null,"medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251015X0002","registration_date":"15/10/2025 11:30","change_notification_approval_date":null,"retention_due_date":"14/10/2026 0:00","product_owner_name":"Phoenix Technology Group, Inc.","product_owner_short_name":"Phoenix Technology Group, Inc.","product_owner_address":"6630 Owens Dr.,, Pleasanton,, CA 94588, United States","registrant_name":"EXCIMED (S) PTE. LTD.","registrant_address":"1, SCOTTS ROAD, #24-10, SHAW CENTRE, Singapore 228208","importer_name":"EXCIMED (S) PTE. LTD.","importer_address":"1, SCOTTS ROAD, #24-10, SHAW CENTRE, Singapore 228208","model_name":"Foot Switch\nHandpiece\nBlue Light LED Module\nWhite Light LED Module\nDiffuser\nControl Box\nPhoenix ICON GO\nPhoenix ICON GO with FA Module","model_identifier":"PCI 30-1000\nPCI 40-1002\nPCI 40-1004\nPCI 40-1005\nPCI 40-1017\nPCI 40-1030\nPCI 40-2001\nPCI 40-2001 + PCI 40-1004"},{"_id":67,"device_name":"Kerr Endodontics TF Adaptive Rotary Files","description":"for root canal shaping and cleaning during endodontic treatment","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251015W0001","registration_date":"15/10/2025 10:32","change_notification_approval_date":null,"retention_due_date":"14/10/2026 0:00","product_owner_name":"Kerr Italia S.r.l.","product_owner_short_name":"Kerr Italia S.r.l.","product_owner_address":"Via Passanti, 174,\nScafati (SA),\n84018,\nItaly, Italy","registrant_name":"EHC COMMERCIAL SINGAPORE PTE. LTD.","registrant_address":"13, STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905","importer_name":"EHC COMMERCIAL SINGAPORE PTE. LTD.","importer_address":"13, STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905","model_name":"TF Adaptive Small Assorted Pack 23mm Length\nTF Adaptive Small Assorted Pack 27mm Length\nTF Adaptive Medium/Large Assorted Pack 23mm Length\nTF Adaptive Medium/Large Assorted Pack 27mm Length\nTF Adaptive File SM1 23mm Length\nTF Adaptive File SM1 27mm Length\nTF Adaptive File SM3 23mm Length\nTF Adaptive File SM3 27mm Length\nTF Adaptive File ML3 23mm Length\nTF Adaptive File ML3 27mm Length\nTF Adaptive File SM2 23mm Length\nTF Adaptive File SM2 27mm Length\nTF Adaptive File ML2 23mm Length\nTF Adaptive File ML2 27mm Length\nTF Adaptive File ML1 23mm Length\nTF Adaptive File ML1 27mm Length","model_identifier":"817-3003\n817-3007\n817-4003\n817-4007\n817-4203\n817-4207\n817-4353\n817-4357\n817-4503\n817-4507\n817-6253\n817-6257\n817-6353\n817-6357\n817-8253\n817-8257"},{"_id":68,"device_name":"Virto I-R","description":"Hearing aid: The hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing.\n\nTinnitus Balance Feature: The feature is intended for use by people with tinnitus who also desire amplification. It provides supplementary noise stimulation which can help defocus the user’s attention from their tinnitus.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251014Z0005","registration_date":"14/10/2025 18:52","change_notification_approval_date":null,"retention_due_date":"13/10/2026 0:00","product_owner_name":"Sonova AG","product_owner_short_name":"Sonova AG","product_owner_address":"Laubisrutistrasse 28, 8712 Stafa Switzerland, Switzerland","registrant_name":"SONOVA SINGAPORE PTE. LTD.","registrant_address":"21, MEDIA CIRCLE, #07-01/04, INFINITE STUDIOS, Singapore 138562","importer_name":"SONOVA SINGAPORE PTE. LTD.","importer_address":"21, MEDIA CIRCLE, #07-01/04, INFINITE STUDIOS, Singapore 138562","model_name":"Phonak Virto I90-R\nPhonak Virto I70-R\nPhonak Virto I50-R\nPhonak Virto I30-R\nmyPhonak 7\nPhonak Target 11","model_identifier":"063-0526-01\n063-0527-01\n063-0528-01\n063-0529-01\n088-0022-00073\n088-0125-00111"},{"_id":69,"device_name":"Nobel Biocare Drill Stop","description":"Intended for use to prepare or support the preparation of an osteotomy for placement of an endosseous dental implant","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251014Y0004","registration_date":"14/10/2025 17:37","change_notification_approval_date":null,"retention_due_date":"13/10/2026 0:00","product_owner_name":"Nobel Biocare AB","product_owner_short_name":"Nobel Biocare AB","product_owner_address":"PO Box 5190, 402 26\nVästra Hamngatan 1\nGöteborg\n411 17\nSweden, Sweden","registrant_name":"EHC COMMERCIAL SINGAPORE PTE. LTD.","registrant_address":"13, STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905","importer_name":"EHC COMMERCIAL SINGAPORE PTE. LTD.","importer_address":"13, STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905","model_name":"Drill Stop Ø2\nDrill Stop Ø2.8\nDrill Stop Ø3\nDrill Stop Ø3.2\nDrill Stop Ø3.4\nDrill Stop Ø3.8\nDrill Stop Ø4.2\nDrill Stop Ø3.6","model_identifier":"33063\n33064\n33075\n33077\n33078\n33080\n33081\n33084"},{"_id":70,"device_name":"Checkpoint Gemini Bipolar Nerve Stimulator","description":"The CHECKPOINT GEMINI™ Nerve Stimulator is a single-use, sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251014X0003","registration_date":"14/10/2025 14:55","change_notification_approval_date":null,"retention_due_date":"13/10/2026 0:00","product_owner_name":"Checkpoint Surgical","product_owner_short_name":"Checkpoint Surgical","product_owner_address":"6050 Oak Tree Boulevard, Independence, Ohio 44131, United States","registrant_name":"GEN-Y (S) PTE. LTD.","registrant_address":"8, JALAN KILANG TIMOR, #03-04A, KEWALRAM HOUSE, Singapore 159305","importer_name":"GEN-Y (S) PTE. LTD.","importer_address":"8, JALAN KILANG TIMOR, #03-04A, KEWALRAM HOUSE, Singapore 159305","model_name":"Checkpoint Gemini Bipolar Nerve Stimulator\nCheckpoint Intraoperative Lead, Small\nCheckpoint Intraoperative Lead, Medium","model_identifier":"9092\n9524\n9525"},{"_id":71,"device_name":"Kanam Latex Industries Molnlycke Proglv Latex Natural rubber latex surgical gloves","description":"Proglv Latex is a disposable medical device is made up of natural rubber latex which is anatomically shaped with thumb position towards the palm side of the index finger which reduces the fatigue on the hands, intended to be worn on the hands usually in surgical settings to provide barrier against potentially infectious fluids and other contaminants.","gmdn_term":"Hevea-latex surgical glove, non-powdered, non-antimicrobial","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251014W0002","registration_date":"14/10/2025 14:54","change_notification_approval_date":null,"retention_due_date":"13/10/2026 0:00","product_owner_name":"Kanam Latex Industries Private Limited","product_owner_short_name":"Kanam Latex Industries Private Limited","product_owner_address":"12/67C, Ananthanadarkudy, Asaripallam (PO), Nagercoil, Kanyakumari District – 629 201, Tamil Nadu, India","registrant_name":"MOLNLYCKE HEALTH CARE ASIA-PACIFIC PTE LTD","registrant_address":"298, TIONG BAHRU ROAD, #07-03, CENTRAL PLAZA, Singapore 168730","importer_name":"MOLNLYCKE HEALTH CARE ASIA-PACIFIC PTE LTD","importer_address":"298, TIONG BAHRU ROAD, #07-03, CENTRAL PLAZA, Singapore 168730","model_name":"Molnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves\nMolnlycke Proglv Latex Natural rubber latex surgical gloves","model_identifier":"2191055\n2191060\n2191065\n2191070\n2191075\n2191080\n2191085\n2191090\n2491055\n2491060\n2491065\n2491070\n2491075\n2491080\n2491085\n2491090"},{"_id":72,"device_name":"Neo Modulus Neocirrus Augmented Gingival Matrix","description":"Augmented Gingival Matrix is intended for augmentation, widening the keratinized gingiva, and deepening the vestibular groove.","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251014V0001","registration_date":"14/10/2025 11:32","change_notification_approval_date":null,"retention_due_date":"13/10/2026 0:00","product_owner_name":"Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.","product_owner_short_name":"Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.","product_owner_address":"Room 301, 302, Building 11, No 8 Jinfeng Road, Suzhou New District, Suzhou, Jiangsu, 215163, China","registrant_name":"QUALTECH CONSULTING CORPORATION PTE. LTD.","registrant_address":"111, NORTH BRIDGE ROAD, #21-01, PENINSULA PLAZA, Singapore 179098","importer_name":null,"importer_address":null,"model_name":"Augmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix\nAugmented Gingival Matrix","model_identifier":"AGM-E-010010\nAGM-E-010020\nAGM-E-010030\nAGM-E-010040\nAGM-E-010050\nAGM-E-010060\nAGM-E-010070\nAGM-E-010080\nAGM-E-020020\nAGM-E-020030\nAGM-E-020040\nAGM-E-020050\nAGM-E-020060\nAGM-E-020070\nAGM-E-020080\nAGM-E-030030\nAGM-E-030040\nAGM-E-030050\nAGM-E-030060\nAGM-E-030070\nAGM-E-030080\nAGM-E-040040\nAGM-E-040050\nAGM-E-040060\nAGM-E-040070\nAGM-E-040080\nAGM-E-050050\nAGM-E-050060\nAGM-E-050070\nAGM-E-050080\nAGM-E-060060\nAGM-E-060070\nAGM-E-060080\nAGM-R-010010\nAGM-R-010020\nAGM-R-010030\nAGM-R-010040\nAGM-R-010050\nAGM-R-010060\nAGM-R-010070\nAGM-R-010080\nAGM-R-020020\nAGM-R-020030\nAGM-R-020040\nAGM-R-020050\nAGM-R-020060\nAGM-R-020070\nAGM-R-020080\nAGM-R-030030\nAGM-R-030040\nAGM-R-030050\nAGM-R-030060\nAGM-R-030070\nAGM-R-030080\nAGM-R-040040\nAGM-R-040050\nAGM-R-040060\nAGM-R-040070\nAGM-R-040080\nAGM-R-050050\nAGM-R-050060\nAGM-R-050070\nAGM-R-050080\nAGM-R-060060\nAGM-R-060070\nAGM-R-060080"},{"_id":73,"device_name":"Zest Anchors LOCATOR® Abutments","description":"The LOCATOR® Abutments are intended to anchor a dental restoration to endosseous implants retained in the mandible or maxilla.","gmdn_term":"Dental implant suprastructure, permanent, preformed","medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251013W0003","registration_date":"13/10/2025 14:58","change_notification_approval_date":null,"retention_due_date":"12/10/2026 0:00","product_owner_name":"Zest Anchors, LLC","product_owner_short_name":"Zest Anchors, LLC","product_owner_address":"2875 Loker Avenue East, Carlsbad, CA 92010, United States","registrant_name":"STRAUMANN GROUP & CLEAR CORRECT SINGAPORE PTE. LTD.","registrant_address":"250, NORTH BRIDGE ROAD, #19-05, RAFFLES CITY TOWER, Singapore 179101","importer_name":"STRAUMANN GROUP & CLEAR CORRECT SINGAPORE PTE. LTD.","importer_address":"250, NORTH BRIDGE ROAD, #19-05, RAFFLES CITY TOWER, Singapore 179101","model_name":"RB/WB LOCATOR® Abutment, GH 1.5mm, coated Ti alloy\nRB/WB LOCATOR® Abutment, GH 2.5mm, coated Ti alloy\nRB/WB LOCATOR® Abutment, GH 3.5mm, coated Ti alloy\nRB/WB LOCATOR® Abutment, GH 4.5mm, coated Ti alloy\nRB/WB LOCATOR® Abutment, GH 5.5mm, coated Ti alloy\nRB/WB LOCATOR® Abutment, GH 6.5mm, coated Ti alloy\nNT LOCATOR® Abutment, H 1mm, coated Ti alloy\nNT LOCATOR® Abutment, H 2mm, coated Ti alloy\nNT LOCATOR® Abutment, H 3mm, coated Ti alloy\nNT LOCATOR® Abutment, H 4mm, coated Ti alloy\nNT LOCATOR® Abutment, H 5mm, coated Ti alloy\nNT LOCATOR® Abutment, H 6mm, coated Ti alloy\nRT LOCATOR® Abutment, H 1mm, coated Ti alloy\nRT LOCATOR® Abutment, H 2mm, coated Ti alloy\nRT LOCATOR® Abutment, H 3mm, coated Ti alloy\nRT LOCATOR® Abutment, H 4mm, coated Ti alloy\nRT LOCATOR® Abutment, H 5mm, coated Ti alloy\nRT LOCATOR® Abutment, H 6mm, coated Ti alloy\nWT LOCATOR® Abutment, H 1mm, coated Ti alloy\nWT LOCATOR® Abutment, H 2mm, coated Ti alloy\nWT LOCATOR® Abutment, H 3mm, coated Ti alloy\nWT LOCATOR® Abutment, H 4mm, coated Ti alloy\nWT LOCATOR® Abutment, H 5mm, coated Ti alloy\nWT LOCATOR® Abutment, H 6mm, coated Ti alloy","model_identifier":"062.5033 (02386)\n062.5034 (02387)\n062.5035 (02388)\n062.5036 (02389)\n062.5037 (02390)\n062.5038 (02391)\n062.5039 (02368)\n062.5040 (02369)\n062.5041 (02370)\n062.5042 (02371)\n062.5043 (02372)\n062.5044 (02373)\n062.5045 (02374)\n062.5046 (02375)\n062.5047 (02376)\n062.5048 (02377)\n062.5049 (02378)\n062.5050 (02379)\n062.5051 (02380)\n062.5052 (02381)\n062.5053 (02382)\n062.5054 (02383)\n062.5055 (02384)\n062.5056 (02385)"},{"_id":74,"device_name":"Roche Molecular Systems cobas® Malaria","description":"The cobas® Malaria test for use on the cobas® 5800/6800/8800 Systems (cobas® Malaria) is a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. It is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating. \nWhole blood samples from all donors may be screened as individual samples. For donations of whole blood and blood components, whole blood samples may be tested individually or in pools comprised of aliquots of individual samples. \nThe test is not intended for use as an aid in diagnosis of Plasmodium infection. \nThis test is not intended for use on samples of cord blood. \nThis test is not intended for use on cadaveric samples. ","gmdn_term":"Plasmodium falciparum nucleic acid IVD, control; Plasmodium falciparum nucleic acid IVD, kit, nucleic acid technique (NAT)","medical_speciality_area":"Microbiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251013V0002","registration_date":"13/10/2025 9:40","change_notification_approval_date":null,"retention_due_date":"12/10/2026 0:00","product_owner_name":"Roche Molecular Systems, Inc","product_owner_short_name":"Roche Molecular Systems, Inc","product_owner_address":"1080 US Highway 202, South Branchburg, NJ 08876, UNITED STATES","registrant_name":"ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD","registrant_address":"8, KALLANG AVENUE, #10-01/09, APERIA, Singapore 339509","importer_name":"ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD","importer_address":"8, KALLANG AVENUE, #10-01/09, APERIA, Singapore 339509","model_name":"cobas NHP Negative Control Kit\ncobas Malaria\ncobas Malaria Control Kit","model_identifier":"09051554190\n09352511190\n09352520190"},{"_id":75,"device_name":"Zhejiang Orient Gene COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)","description":"The COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative and differential detection of SARS-CoV-2, influenza A, influenza B, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) antigens in nasal swab specimens directly from individuals within the first seven days of symptom onset. It is intended to aid in the rapid diagnosis of SARS-CoV-2, influenza A, influenza B, RSV and Adenovirus infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) must be confirmed with alternative testing method(s) and clinical findings. It is for in vitro diagnosis use only. It is not automated. It is intended for Self-testing use and not for near patient use.","gmdn_term":"Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing","medical_speciality_area":"Microbiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251013U0001","registration_date":"13/10/2025 7:44","change_notification_approval_date":null,"retention_due_date":"12/10/2026 0:00","product_owner_name":"Zhejiang Orient Gene Biotech Co., Ltd.","product_owner_short_name":"Zhejiang Orient Gene Biotech Co., Ltd.","product_owner_address":"3787#, East Yangguang Avenue, Dipu Street, Anji, 313300 Zhejiang, China., China","registrant_name":"MEDICO PTE. LTD.","registrant_address":"27, NEW INDUSTRIAL ROAD, #03-03, NOVELTY TECHPOINT, Singapore 536212","importer_name":"MEDICO PTE. LTD.","importer_address":"27, NEW INDUSTRIAL ROAD, #03-03, NOVELTY TECHPOINT, Singapore 536212","model_name":"COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)\nCOVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)\nCOVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)\nCOVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)","model_identifier":"GCFCRA-T525a-DRH1\nGCFCRA-T525a-DRH20\nGCFCRA-T525a-DRH5\nGCFCRA-T525a-DRH7"},{"_id":76,"device_name":"Starkey Omega AI Hearing Aids (ITE, Wireless, Digital)","description":"An air conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251012V0003","registration_date":"12/10/2025 18:53","change_notification_approval_date":null,"retention_due_date":"11/10/2026 0:00","product_owner_name":"Starkey Laboratories Inc.","product_owner_short_name":"Starkey Laboratories Inc.","product_owner_address":"6700 Washington Avenue S,, Eden Prairie, Minnesota, 55344 United States, United States","registrant_name":"STARKEY HEARING TECHNOLOGIES SINGAPORE PTE. LTD.","registrant_address":"151, LORONG CHUAN, #03-01B, NEW TECH PARK, Singapore 556741","importer_name":"STARKEY HEARING TECHNOLOGIES SINGAPORE PTE. LTD.","importer_address":"151, LORONG CHUAN, #03-01B, NEW TECH PARK, Singapore 556741","model_name":"Starkey Omega AI 24 ITE R\nStarkey Omega AI 20 ITE R\nStarkey Omega AI 16 ITE R\nStarkey Omega AI 24 ITC R\nStarkey Omega AI 20 ITC R\nStarkey Omega AI 16 ITC R\nStarkey Omega AI 24 HS R\nStarkey Omega AI 20 HS R\nStarkey Omega AI 16 HS R\nStarkey Omega AI 24 CIC\nStarkey Omega AI 20 CIC\nStarkey Omega AI 16 CIC","model_identifier":"72144-SHT\n72145-SHT\n72146-SHT\n72147-SHT\n72148-SHT\n72149-SHT\n72150-SHT\n72151-SHT\n72152-SHT\n72153-SHT\n72154-SHT\n72155-SHT"},{"_id":77,"device_name":"Starkey Omega AI Hearing Aids (BTE, Wireless, Digital)","description":"An air conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing.","gmdn_term":null,"medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251012U0002","registration_date":"12/10/2025 18:24","change_notification_approval_date":null,"retention_due_date":"11/10/2026 0:00","product_owner_name":"Starkey Laboratories Inc.","product_owner_short_name":"Starkey Laboratories Inc.","product_owner_address":"6700 Washington Avenue S,, Eden Prairie, Minnesota, 55344 United States, United States","registrant_name":"STARKEY HEARING TECHNOLOGIES SINGAPORE PTE. LTD.","registrant_address":"151, LORONG CHUAN, #03-01B, NEW TECH PARK, Singapore 556741","importer_name":"STARKEY HEARING TECHNOLOGIES SINGAPORE PTE. LTD.","importer_address":"151, LORONG CHUAN, #03-01B, NEW TECH PARK, Singapore 556741","model_name":"Pro Fit Fitting Software\nMy Starkey\nMy Starkey\nStarkey Omega AI 24 RIC RT\nStarkey Omega AI 24 RIC RT\nStarkey Omega AI 24 RIC RT\nStarkey Omega AI 24 RIC RT\nStarkey Omega AI 24 RIC RT\nStarkey Omega AI 24 RIC RT\nStarkey Omega AI 24 RIC RT\nStarkey Omega AI Cros RIC RT\nStarkey Omega AI Cros RIC RT\nStarkey Omega AI Cros RIC RT\nStarkey Omega AI Cros RIC RT\nStarkey Omega AI Cros RIC RT\nStarkey Omega AI Cros RIC RT\nStarkey Omega AI Cros RIC RT\nStarkey Omega AI 20 RIC RT\nStarkey Omega AI 20 RIC RT\nStarkey Omega AI 20 RIC RT\nStarkey Omega AI 20 RIC RT\nStarkey Omega AI 20 RIC RT\nStarkey Omega AI 20 RIC RT\nStarkey Omega AI 20 RIC RT\nStarkey Omega AI 16 RIC RT\nStarkey Omega AI 16 RIC RT\nStarkey Omega AI 16 RIC RT\nStarkey Omega AI 16 RIC RT\nStarkey Omega AI 16 RIC RT\nStarkey Omega AI 16 RIC RT\nStarkey Omega AI 16 RIC RT\nStarkey Omega AI 24 mRIC R\nStarkey Omega AI 24 mRIC R\nStarkey Omega AI 24 mRIC R\nStarkey Omega AI 24 mRIC R\nStarkey Omega AI 24 mRIC R\nStarkey Omega AI 24 mRIC R\nStarkey Omega AI 24 mRIC R\nStarkey Omega AI 20 mRIC R\nStarkey Omega AI 20 mRIC R\nStarkey Omega AI 20 mRIC R\nStarkey Omega AI 20 mRIC R\nStarkey Omega AI 20 mRIC R\nStarkey Omega AI 20 mRIC R\nStarkey Omega AI 20 mRIC R\nStarkey Omega AI 16 mRIC R\nStarkey Omega AI 16 mRIC R\nStarkey Omega AI 16 mRIC R\nStarkey Omega AI 16 mRIC R\nStarkey Omega AI 16 mRIC R\nStarkey Omega AI 16 mRIC R\nStarkey Omega AI 16 mRIC R\nStarkey Omega AI 24 RIC 312\nStarkey Omega AI 24 RIC 312\nStarkey Omega AI 24 RIC 312\nStarkey Omega AI 24 RIC 312\nStarkey Omega AI 24 RIC 312\nStarkey Omega AI 24 RIC 312\nStarkey Omega AI 24 RIC 312\nStarkey Omega AI Cros RIC 312\nStarkey Omega AI Cros RIC 312\nStarkey Omega AI Cros RIC 312\nStarkey Omega AI Cros RIC 312\nStarkey Omega AI Cros RIC 312\nStarkey Omega AI Cros RIC 312\nStarkey Omega AI Cros RIC 312\nStarkey Omega AI 20 RIC 312\nStarkey Omega AI 20 RIC 312\nStarkey Omega AI 20 RIC 312\nStarkey Omega AI 20 RIC 312\nStarkey Omega AI 20 RIC 312\nStarkey Omega AI 20 RIC 312\nStarkey Omega AI 20 RIC 312\nStarkey Omega AI 16 RIC 312\nStarkey Omega AI 16 RIC 312\nStarkey Omega AI 16 RIC 312\nStarkey Omega AI 16 RIC 312\nStarkey Omega AI 16 RIC 312\nStarkey Omega AI 16 RIC 312\nStarkey Omega AI 16 RIC 312","model_identifier":"2025.1.10185.0\n5.0.1\n5.0.1\n63381-123\n63381-131\n63381-138\n63381-139\n63381-140\n63381-141\n63381-143\n63382-123\n63382-131\n63382-138\n63382-139\n63382-140\n63382-141\n63382-143\n63383-123\n63383-131\n63383-138\n63383-139\n63383-140\n63383-141\n63383-143\n63384-123\n63384-131\n63384-138\n63384-139\n63384-140\n63384-141\n63384-143\n63391-123\n63391-131\n63391-138\n63391-139\n63391-140\n63391-141\n63391-143\n63392-123\n63392-131\n63392-138\n63392-139\n63392-140\n63392-141\n63392-143\n63393-123\n63393-131\n63393-138\n63393-139\n63393-140\n63393-141\n63393-143\n63413-123\n63413-131\n63413-138\n63413-139\n63413-140\n63413-141\n63413-143\n63414-123\n63414-131\n63414-138\n63414-139\n63414-140\n63414-141\n63414-143\n63415-123\n63415-131\n63415-138\n63415-139\n63415-140\n63415-141\n63415-143\n63416-123\n63416-131\n63416-138\n63416-139\n63416-140\n63416-141\n63416-143"},{"_id":78,"device_name":"Visionix Handheld Auto Refractor / Keratometer Retinomax","description":"Retinomax is an objective refractometer offering capabilities of measuring refractive power, corneal shape, and pupil diameter.","gmdn_term":null,"medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251012T0001","registration_date":"12/10/2025 12:32","change_notification_approval_date":null,"retention_due_date":"11/10/2026 0:00","product_owner_name":"LUNEAU TECHNOLOGY OPERATIONS","product_owner_short_name":"LUNEAU TECHNOLOGY OPERATIONS","product_owner_address":"2 RUE ROGER BONNET, 27340 PONT-DE-L'ARCHE, France","registrant_name":"VITOP PTE. LTD.","registrant_address":"15, LORONG 8 TOA PAYOH, #04-03, BRADDELL TECH, Singapore 319262","importer_name":"VITOP PTE. LTD.","importer_address":"15, LORONG 8 TOA PAYOH, #04-03, BRADDELL TECH, Singapore 319262","model_name":"Retinomax 5\nRetinomax 5\nRetinomax K-plus 5\nRetinomax K-plus 5\nRetinomax Screeen\nRetinomax Screeen\nRetinomax K+Sceeen\nRetinomax K+Screeen","model_identifier":"VSN5100BG\nVSN5100TG\nVSN5200BG\nVSN5200TG\nVSN5300BG\nVSN5300TG\nVSN5400BG\nVSN5400TG"},{"_id":79,"device_name":"Zhejiang CuraWay Automatic Core Biopsy Instrument","description":"Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft\ntissues such as liver, kidney, breast, prostate, spleen, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone.","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251010T0003","registration_date":"10/10/2025 16:31","change_notification_approval_date":null,"retention_due_date":"9/10/2026 0:00","product_owner_name":"Zhejiang Curaway Medical Technology Co., Ltd.","product_owner_short_name":"Zhejiang Curaway Medical Technology Co., Ltd.","product_owner_address":"Room 106, Building 1, #600, 21st Street, Qiantang New Area, Hangzhou, Zhejiang, Hangzhou, Zhejiang, China","registrant_name":"TOPMED PTE. LTD.","registrant_address":"10, BUKIT BATOK CRESCENT, #10-02, THE SPIRE, Singapore 658079","importer_name":"TOPMED PTE. LTD.","importer_address":"10, BUKIT BATOK CRESCENT, #10-02, THE SPIRE, Singapore 658079","model_name":"Automatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument\nAutomatic Core Biopsy Instrument","model_identifier":"BN-OCR-1/1208\nBN-OCR-1/1209\nBN-OCR-1/1210\nBN-OCR-1/1213\nBN-OCR-1/1215\nBN-OCR-1/1216\nBN-OCR-1/1218\nBN-OCR-1/1220\nBN-OCR-1/1225\nBN-OCR-1/1408\nBN-OCR-1/1409\nBN-OCR-1/1410\nBN-OCR-1/1413\nBN-OCR-1/1415\nBN-OCR-1/1416\nBN-OCR-1/1418\nBN-OCR-1/1420\nBN-OCR-1/1425\nBN-OCR-1/1608\nBN-OCR-1/1609\nBN-OCR-1/1610\nBN-OCR-1/1613\nBN-OCR-1/1615\nBN-OCR-1/1616\nBN-OCR-1/1618\nBN-OCR-1/1620\nBN-OCR-1/1625\nBN-OCR-1/1808\nBN-OCR-1/1809\nBN-OCR-1/1810\nBN-OCR-1/1813\nBN-OCR-1/1815\nBN-OCR-1/1816\nBN-OCR-1/1818\nBN-OCR-1/1820\nBN-OCR-1/1825\nBN-OCR-1/2008\nBN-OCR-1/2009\nBN-OCR-1/2010\nBN-OCR-1/2013\nBN-OCR-1/2015\nBN-OCR-1/2016\nBN-OCR-1/2018\nBN-OCR-1/2020\nBN-OCR-1/2025\nBN-OCR-13/1408\nBN-OCR-13/1410\nBN-OCR-13/1413\nBN-OCR-13/1416\nBN-OCR-13/1420\nBN-OCR-13/1425\nBN-OCR-13/1608\nBN-OCR-13/1610\nBN-OCR-13/1613\nBN-OCR-13/1616\nBN-OCR-13/1620\nBN-OCR-13/1625\nBN-OCR-13/1808\nBN-OCR-13/1810\nBN-OCR-13/1813\nBN-OCR-13/1816\nBN-OCR-13/1820\nBN-OCR-13/1825\nBN-OCR-13/2008\nBN-OCR-13/2010\nBN-OCR-13/2013\nBN-OCR-13/2016\nBN-OCR-13/2020\nBN-OCR-13/2025\nBN-OCR-2/1208\nBN-OCR-2/1209\nBN-OCR-2/1210\nBN-OCR-2/1213\nBN-OCR-2/1215\nBN-OCR-2/1216\nBN-OCR-2/1218\nBN-OCR-2/1220\nBN-OCR-2/1225\nBN-OCR-2/1408\nBN-OCR-2/1409\nBN-OCR-2/1410\nBN-OCR-2/1413\nBN-OCR-2/1415\nBN-OCR-2/1416\nBN-OCR-2/1418\nBN-OCR-2/1420\nBN-OCR-2/1425\nBN-OCR-2/1608\nBN-OCR-2/1609\nBN-OCR-2/1610\nBN-OCR-2/1613\nBN-OCR-2/1615\nBN-OCR-2/1616\nBN-OCR-2/1618\nBN-OCR-2/1620\nBN-OCR-2/1625\nBN-OCR-2/1808\nBN-OCR-2/1809\nBN-OCR-2/1810\nBN-OCR-2/1813\nBN-OCR-2/1815\nBN-OCR-2/1816\nBN-OCR-2/1818\nBN-OCR-2/1820\nBN-OCR-2/1825\nBN-OCR-2/2008\nBN-OCR-2/2009\nBN-OCR-2/2010\nBN-OCR-2/2013\nBN-OCR-2/2015\nBN-OCR-2/2016\nBN-OCR-2/2018\nBN-OCR-2/2020\nBN-OCR-2/2025\nBN-OCR-3/1208\nBN-OCR-3/1209\nBN-OCR-3/1210\nBN-OCR-3/1213\nBN-OCR-3/1215\nBN-OCR-3/1216\nBN-OCR-3/1218\nBN-OCR-3/1220\nBN-OCR-3/1225\nBN-OCR-3/1408\nBN-OCR-3/1409\nBN-OCR-3/1410\nBN-OCR-3/1413\nBN-OCR-3/1415\nBN-OCR-3/1416\nBN-OCR-3/1418\nBN-OCR-3/1420\nBN-OCR-3/1425\nBN-OCR-3/1608\nBN-OCR-3/1609\nBN-OCR-3/1610\nBN-OCR-3/1613\nBN-OCR-3/1615\nBN-OCR-3/1616\nBN-OCR-3/1618\nBN-OCR-3/1620\nBN-OCR-3/1625\nBN-OCR-3/1808\nBN-OCR-3/1809\nBN-OCR-3/1810\nBN-OCR-3/1813\nBN-OCR-3/1815\nBN-OCR-3/1816\nBN-OCR-3/1818\nBN-OCR-3/1820\nBN-OCR-3/1825\nBN-OCR-3/2008\nBN-OCR-3/2009\nBN-OCR-3/2010\nBN-OCR-3/2013\nBN-OCR-3/2015\nBN-OCR-3/2016\nBN-OCR-3/2018\nBN-OCR-3/2020\nBN-OCR-3/2025\nBN-OCR-6/1208\nBN-OCR-6/1209\nBN-OCR-6/1210\nBN-OCR-6/1213\nBN-OCR-6/1215\nBN-OCR-6/1216\nBN-OCR-6/1218\nBN-OCR-6/1220\nBN-OCR-6/1225\nBN-OCR-6/1408\nBN-OCR-6/1409\nBN-OCR-6/1410\nBN-OCR-6/1413\nBN-OCR-6/1415\nBN-OCR-6/1416\nBN-OCR-6/1418\nBN-OCR-6/1420\nBN-OCR-6/1425\nBN-OCR-6/1608\nBN-OCR-6/1609\nBN-OCR-6/1610\nBN-OCR-6/1613\nBN-OCR-6/1615\nBN-OCR-6/1616\nBN-OCR-6/1618\nBN-OCR-6/1620\nBN-OCR-6/1625\nBN-OCR-6/1808\nBN-OCR-6/1809\nBN-OCR-6/1810\nBN-OCR-6/1813\nBN-OCR-6/1815\nBN-OCR-6/1816\nBN-OCR-6/1818\nBN-OCR-6/1820\nBN-OCR-6/1825\nBN-OCR-6/2008\nBN-OCR-6/2009\nBN-OCR-6/2010\nBN-OCR-6/2013\nBN-OCR-6/2015\nBN-OCR-6/2016\nBN-OCR-6/2018\nBN-OCR-6/2020\nBN-OCR-6/2025\nBN-OCR-7/1208\nBN-OCR-7/1209\nBN-OCR-7/1210\nBN-OCR-7/1213\nBN-OCR-7/1215\nBN-OCR-7/1216\nBN-OCR-7/1218\nBN-OCR-7/1220\nBN-OCR-7/1225\nBN-OCR-7/1408\nBN-OCR-7/1409\nBN-OCR-7/1410\nBN-OCR-7/1413\nBN-OCR-7/1415\nBN-OCR-7/1416\nBN-OCR-7/1418\nBN-OCR-7/1420\nBN-OCR-7/1425\nBN-OCR-7/1608\nBN-OCR-7/1609\nBN-OCR-7/1610\nBN-OCR-7/1613\nBN-OCR-7/1615\nBN-OCR-7/1616\nBN-OCR-7/1618\nBN-OCR-7/1620\nBN-OCR-7/1625\nBN-OCR-7/1808\nBN-OCR-7/1809\nBN-OCR-7/1810\nBN-OCR-7/1813\nBN-OCR-7/1815\nBN-OCR-7/1816\nBN-OCR-7/1818\nBN-OCR-7/1820\nBN-OCR-7/1825\nBN-OCR-7/2008\nBN-OCR-7/2009\nBN-OCR-7/2010\nBN-OCR-7/2013\nBN-OCR-7/2015\nBN-OCR-7/2016\nBN-OCR-7/2018\nBN-OCR-7/2020\nBN-OCR-7/2025\nBN-OCR-8/1208\nBN-OCR-8/1209\nBN-OCR-8/1210\nBN-OCR-8/1213\nBN-OCR-8/1215\nBN-OCR-8/1216\nBN-OCR-8/1218\nBN-OCR-8/1220\nBN-OCR-8/1225\nBN-OCR-8/1408\nBN-OCR-8/1409\nBN-OCR-8/1410\nBN-OCR-8/1413\nBN-OCR-8/1415\nBN-OCR-8/1416\nBN-OCR-8/1418\nBN-OCR-8/1420\nBN-OCR-8/1425\nBN-OCR-8/1608\nBN-OCR-8/1609\nBN-OCR-8/1610\nBN-OCR-8/1613\nBN-OCR-8/1615\nBN-OCR-8/1616\nBN-OCR-8/1618\nBN-OCR-8/1620\nBN-OCR-8/1625\nBN-OCR-8/1808\nBN-OCR-8/1809\nBN-OCR-8/1810\nBN-OCR-8/1813\nBN-OCR-8/1815\nBN-OCR-8/1816\nBN-OCR-8/1818\nBN-OCR-8/1820\nBN-OCR-8/1825\nBN-OCR-8/2008\nBN-OCR-8/2009\nBN-OCR-8/2010\nBN-OCR-8/2013\nBN-OCR-8/2015\nBN-OCR-8/2016\nBN-OCR-8/2018\nBN-OCR-8/2020\nBN-OCR-8/2025\nBN-OCR-9/1208\nBN-OCR-9/1209\nBN-OCR-9/1210\nBN-OCR-9/1213\nBN-OCR-9/1215\nBN-OCR-9/1216\nBN-OCR-9/1218\nBN-OCR-9/1220\nBN-OCR-9/1225\nBN-OCR-9/1408\nBN-OCR-9/1409\nBN-OCR-9/1410\nBN-OCR-9/1413\nBN-OCR-9/1415\nBN-OCR-9/1416\nBN-OCR-9/1418\nBN-OCR-9/1420\nBN-OCR-9/1425\nBN-OCR-9/1608\nBN-OCR-9/1609\nBN-OCR-9/1610\nBN-OCR-9/1613\nBN-OCR-9/1615\nBN-OCR-9/1616\nBN-OCR-9/1618\nBN-OCR-9/1620\nBN-OCR-9/1625\nBN-OCR-9/1808\nBN-OCR-9/1809\nBN-OCR-9/1810\nBN-OCR-9/1813\nBN-OCR-9/1815\nBN-OCR-9/1816\nBN-OCR-9/1818\nBN-OCR-9/1820\nBN-OCR-9/1825\nBN-OCR-9/2008\nBN-OCR-9/2009\nBN-OCR-9/2010\nBN-OCR-9/2013\nBN-OCR-9/2015\nBN-OCR-9/2016\nBN-OCR-9/2018\nBN-OCR-9/2020\nBN-OCR-9/2025"},{"_id":80,"device_name":"Rexxam Specular Microscope SPM-700","description":"This product (SPM-700) aims to capture the images of the corneal endothelial cells by projecting the illuminating light onto a subject’s cornea","gmdn_term":null,"medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251010S0002","registration_date":"10/10/2025 14:11","change_notification_approval_date":null,"retention_due_date":"9/10/2026 0:00","product_owner_name":"Rexxam Co., Ltd.","product_owner_short_name":"Rexxam Co., Ltd.","product_owner_address":"958 Ikeuchi, Konan-cho, Takamatsu-shi, Kagawa, 761-1494, Japan, Japan","registrant_name":"OPHTHALMIC INSTRUMENTS (PTE. LTD.)","registrant_address":"65, UBI ROAD 1, #03-74, OXLEY BIZHUB, Singapore 408729","importer_name":"OPHTHALMIC INSTRUMENTS (PTE. LTD.)","importer_address":"65, UBI ROAD 1, #03-74, OXLEY BIZHUB, Singapore 408729","model_name":"Specular Microscope","model_identifier":"SPM-700"},{"_id":81,"device_name":"Covidien MaxTack™ Motorized Fixation Device","description":"The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.\nThe intended purpose of the device is fixation of prosthetic material.","gmdn_term":"Endoscopic manual linear cutting stapler, single-use","medical_speciality_area":"General & Plastic Surgery","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251010R0001","registration_date":"10/10/2025 7:52","change_notification_approval_date":null,"retention_due_date":"9/10/2026 0:00","product_owner_name":"COVIDIEN LLC","product_owner_short_name":"COVIDIEN LLC","product_owner_address":"15 Hampshire Street, Mansfield, Massachusetts, 02048, United States","registrant_name":"COVIDIEN PRIVATE LIMITED","registrant_address":"50, PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384","importer_name":"COVIDIEN PRIVATE LIMITED","importer_address":"50, PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384","model_name":"MaxTack™ Motorized Fixation Device","model_identifier":"MAXTACK30"},{"_id":82,"device_name":"Elixir Medical LithiX Hertz Contact Intravascular Lithotripsy Catheter","description":"The LithiX Hertz Contact Intravascular Lithotripsy Catheter is intended to treat calcified stenoses by calcium fragmentation. The LithiX Hertz Contact Intravascular Lithotripsy Catheter is indicated for calcium fragmentation of moderate to severely calcified, stenotic de novo coronary artery lesions prior to stenting.","gmdn_term":"Intravascular lithotripsy system balloon catheter, coronary","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251009A0002","registration_date":"9/10/2025 10:30","change_notification_approval_date":null,"retention_due_date":"8/10/2026 0:00","product_owner_name":"Elixir Medical Corporation","product_owner_short_name":"Elixir Medical Corporation","product_owner_address":"920 North McCarthy Boulevard, Milpitas, CA 95035, United States","registrant_name":"ASIA ACTUAL PTE. LTD.","registrant_address":"116, CHANGI ROAD, #04-05, WIS@CHANGI, Singapore 419718","importer_name":"ALCARE PHARMACEUTICALS PTE LTD","importer_address":"12A, JALAN AMPAS, #03-03, BALESTIER WAREHOUSE BUILDING, Singapore 329516","model_name":"LithiX Hertz Contact Intravascular Lithotripsy Catheter\nLithiX Hertz Contact Intravascular Lithotripsy Catheter\nLithiX Hertz Contact Intravascular Lithotripsy Catheter\nLithiX Hertz Contact Intravascular Lithotripsy Catheter\nLithiX Hertz Contact Intravascular Lithotripsy Catheter\nLithiX Hertz Contact Intravascular Lithotripsy Catheter\nLithiX Hertz Contact Intravascular Lithotripsy Catheter\nLithiX Hertz Contact Intravascular Lithotripsy Catheter","model_identifier":"DAR1514\nDAR2014\nDAR2214\nDAR2514\nDAR2714\nDAR3014\nDAR3214\nDAR3514"},{"_id":83,"device_name":"MC3 Nautilus™ Smart ECMO Module with Balance™ Biosurface\t\t\t","description":"The MC3 ECMO Oxygenator with integrated heat exchanger is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood for up to 14 days in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built in sensor modules and display.","gmdn_term":"Extracorporeal membrane oxygenator","medical_speciality_area":"Cardiovascular","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251009Z0001","registration_date":"9/10/2025 7:47","change_notification_approval_date":null,"retention_due_date":"8/10/2026 0:00","product_owner_name":"MC3, Inc","product_owner_short_name":"MC3, Inc","product_owner_address":"2555 Bishop Circle West, Dexter, MI 48130, United States","registrant_name":"MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)","registrant_address":"50, PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384","importer_name":"MEDTRONIC INTERNATIONAL TRADING PTE. LTD.; MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)","importer_address":"50, PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384","model_name":"Nautilus™ Smart ECMO Module with Balance™ Biosurface","model_identifier":"48135E"},{"_id":84,"device_name":"Christoph Miethke M.blue® Shunt System","description":"M.blue(Plus) is used for cerebrospinal fluid (CSF) drainage in the treatment of hydrocephalus","gmdn_term":"Cerebrospinal fluid shunt valve/port/reservoir","medical_speciality_area":"Neurology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251008G0009","registration_date":"8/10/2025 16:49","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"Christoph Miethke GmbH & Co. KG","product_owner_short_name":"Christoph Miethke GmbH & Co. KG","product_owner_address":"Ulanenweg 2, 14469 Potsdam, Germany","registrant_name":"B. BRAUN SINGAPORE PTE. LTD.","registrant_address":"18, NEPAL PARK, #02-02, Singapore 139407","importer_name":"B. BRAUN SINGAPORE PTE. LTD.","importer_address":"18, NEPAL PARK, #02-02, Singapore 139407","model_name":"M.blue\nM.blue\nM.blue\nM.blue\nM.blue plus\nM.blue with distal catheter\nM.blue with distal catheter\nM.blue with distal catheter\nM.blue with distal catheter\nM.blue plus with distal catheter\nM.blue Shunt System\nM.blue Shunt System\nM.blue Shunt System\nM.blue Shunt System\nM.blue plus Shunt System\nM.blue Shunt System with pediatric CONTROL RESERVOIR\nM.blue Shunt System with pediatric CONTROL RESERVOIR\nM.blue Shunt System with pediatric CONTROL RESERVOIR\nM.blue Shunt System with pediatric CONTROL RESERVOIR\nM.blue plus Shunt System with pediatric CONTROL RESERVOIR\nM.blue Shunt System with CONTROL RESERVOIR\nM.blue Shunt System with CONTROL RESERVOIR\nM.blue Shunt System with CONTROL RESERVOIR\nM.blue Shunt System with CONTROL RESERVOIR\nM.blue plus Shunt System with CONTROL RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue plus Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue plus Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with pediatric SPRUNG RESERVOIR\nM.blue plus Shunt System with pediatric SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with SPRUNG RESERVOIR\nM.blue plus Shunt System with SPRUNG RESERVOIR\nM.blue Shunt System with pediatric burrhole reservoir\nM.blue Shunt System with pediatric burrhole reservoir\nM.blue Shunt System with pediatric burrhole reservoir\nM.blue Shunt System with pediatric burrhole reservoir\nM.blue plus Shunt System with pediatric burrhole reservoir","model_identifier":"FX800T\nFX801T\nFX802T\nFX803T\nFX804T\nFX805T\nFX806T\nFX807T\nFX808T\nFX809T\nFX810T\nFX811T\nFX812T\nFX813T\nFX814T\nFX815T\nFX816T\nFX817T\nFX818T\nFX819T\nFX820T\nFX821T\nFX822T\nFX823T\nFX824T\nFX825T\nFX826T\nFX827T\nFX828T\nFX829T\nFX830T\nFX831T\nFX832T\nFX833T\nFX834T\nFX835T\nFX836T\nFX837T\nFX838T\nFX839T\nFX840T\nFX841T\nFX842T\nFX843T\nFX844T\nFX845T\nFX846T\nFX847T\nFX848T\nFX849T"},{"_id":85,"device_name":"Synthes Intrapelvic Acetabular System 3.5 mm","description":"Intrapelvic Acetabular Plates 3.5 mm are intended for temporary fixation, correction, or stabilization of bones. The Intrapelvic Acetabular Plates 3.5 mm are indicated for fractures of the acetabulum.","gmdn_term":"Orthopaedic fixation plate, non-bioabsorbable","medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251008F0008","registration_date":"8/10/2025 16:48","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"Synthes GmbH","product_owner_short_name":"Synthes GmbH","product_owner_address":"Eimattstrasse 3, CH-4436 Oberdorf, Switzerland","registrant_name":"JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.","registrant_address":"2, SCIENCE PARK DRIVE, #07-13, ASCENT, Singapore 118222","importer_name":"JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.","importer_address":"2, SCIENCE PARK DRIVE, #07-13, ASCENT, Singapore 118222","model_name":"Intrapelvic Acetabular Plate 3.5 mm, large, right, standard\nIntrapelvic Acetabular Plate 3.5 mm, large, right, extended\nIntrapelvic Acetabular Plate 3.5 mm, large, left, standard\nIntrapelvic Acetabular Plate 3.5 mm, large, left, extended\nIntrapelvic Acetabular Plate 3.5 mm, small, right, standard\nIntrapelvic Acetabular Plate 3.5 mm, small, right, extended\nIntrapelvic Acetabular Plate 3.5 mm, small, left, standard\nIntrapelvic Acetabular Plate 3.5 mm, small, left, extended\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 10 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 10 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 10 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 12 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 12 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 12 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 14 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 14 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 14 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 16 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 16 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 16 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 18 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 18 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 18 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 20 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 20 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 20 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 22 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 22 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 22 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 24 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 24 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 24 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 26 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 26 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 26 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 28 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 28 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 28 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 30 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 30 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 30 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 32 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 32 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 32 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 34 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 34 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 34 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 36 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 36 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 36 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 38 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 38 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 38 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 40 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 40 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 40 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 42 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 42 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 42 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 44 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 44 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 44 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 45 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 45 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 45 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 46 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 46 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 46 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 48 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 48 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 48 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 50 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 50 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 50 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 55 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 55 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 55 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 60 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 60 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 60 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 65 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 65 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 65 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 70 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 70 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 70 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 75 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 75 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 75 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 80 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 80 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 80 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 85 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 85 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 85 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 90 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 90 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 90 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 95 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 95 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 95 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 100 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 100 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 100 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 105 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 105 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 105 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 110 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 110 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 110 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 115 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 115 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 115 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 120 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 120 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 120 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 125 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 125 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 125 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 130 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 130 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 130 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 135 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 135 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 135 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 140 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 140 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 140 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 145 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 145 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 150 mm\nCortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 150 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 10 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 10 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 10 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 12 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 12 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 12 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 14 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 14 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 14 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 16 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 16 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 16 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 18 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 18 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 18 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 20 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 20 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 20 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 22 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 22 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 22 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 24 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 24 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 24 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 26 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 26 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 26 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 28 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 28 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 28 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 30 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 30 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 30 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 32 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 32 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 32 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 34 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 34 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 34 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 36 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 36 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 36 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 38 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 38 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 38 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 40 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 40 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 40 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 42 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 42 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 42 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 44 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 44 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 44 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 45 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 45 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 45 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 46 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 46 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 46 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 48 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 48 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 48 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 50 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 50 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 50 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 52 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 52 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 52 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 54 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 54 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 54 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 56 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 56 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 56 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 58 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 58 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 58 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 60 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 60 mm\nLow Profile Cortex Screw Stardrive® Ø 3.5 mm, self-tapp., L 60 mm\nSizing Trial f/Intrapel.Acetab.Pl. 3.5 mm, large, right, standard\nSizing Trial f/Intrapel.Acetab.Pl. 3.5 mm, large, left, standard\nSizing Trial f/Intrapel.Acetab.Pl. 3.5 mm, small, right, standard\nSizing Trial f/Intrapel.Acetab.Pl. 3.5 mm, small, left, standard\nRadiolucent Pelvic Retractor, f/superior pubic ramus\nRadiolucent Pelvic Retractor, f/iliac fossa\nRadiolucent Pelvic Retractor, f/quadrilateral surface\nDrill Bit Ø 2.5 mm, Quick Coupling, L 400 mm, Calibration up to 120 mm\nDrill Bit Ø 2.5 mm, Quick Coupling, L 400 mm, Calibration up to 120 mm\nDrill Bit Ø 3.5 mm, Quick Coupling, L 380 mm\nDrill Bit Ø 3.5 mm, Quick Coupling, L 380 mm\nScrewdriver Shaft, hexagonal 2.5 mm, self-holding, L 300 mm, f/Quick Coupling\nScrewdriver Shaft Stardrive 3.5, T15, L 300 mm, f/Quick Coupling\nTemporary Fixation Wire Ø 2.5 mm, L 220 mm\nTemporary Fixation Wire Ø 2.5 mm, L 220 mm\nTemporary Fixation Wire Ø 2.5 mm, L 150 mm\nTemporary Fixation Wire Ø 2.5 mm, L 150 mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 30mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 30mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 30mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 35mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 35mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 35mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 40mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 40mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 40mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 45mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 45mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 45mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 50mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 50mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 50mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 55mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 55mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 55mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 60mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 60mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 60mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 65mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 65mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 65mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 70mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 70mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 70mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 75mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 75mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 75mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 80mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 80mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 80mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 85mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 85mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 85mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 90mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 90mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 90mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 95mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 95mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 95mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 100mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 100mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 100mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 105mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 105mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 105mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 110mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 110mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 110mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 115mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 115mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 115mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 120mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 120mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 120mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 125mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 125mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 125mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 130mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 130mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 130mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 135mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 135mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 135mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 140mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 140mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 140mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 145mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 145mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 150mm\nPelvic Cortex Screw Ø3.5mm, self-tapp., L 150mm\nCortex Screw Ø 3.5 mm, self-tapp., L 10 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 10 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 12 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 12 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 14 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 14 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 16 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 16 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 18 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 18 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 20 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 20 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 22 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 22 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 24 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 24 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 26 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 26 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 28 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 28 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 30 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 30 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 32 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 32 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 34 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 34 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 36 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 36 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 38 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 38 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 40 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 40 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 42 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 42 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 44 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 44 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 45 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 45 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 46 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 46 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 48 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 48 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 50 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 50 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 55 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 55 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 60 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 60 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 65 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 65 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 70 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 70 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 75 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 75 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 80 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 80 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 85 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 85 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 90 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 90 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 95 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 95 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 100 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 100 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 105 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 105 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 110 mm\nCortex Screw Ø 3.5 mm, self-tapp., L 110 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 14 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 14 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 14 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 16 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 16 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 16 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 18 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 18 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 18 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 20 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 20 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 20 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 22 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 22 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 22 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 24 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 24 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 24 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 26 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 26 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 26 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 28 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 28 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 28 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 30 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 30 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 30 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 32 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 32 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 32 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 34 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 34 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 34 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 36 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 36 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 36 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 38 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 38 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 38 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 40 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 40 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 40 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 42 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 42 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 42 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 44 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 44 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 44 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 46 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 46 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 46 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 48 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 48 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 48 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 50 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 50 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 50 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 52 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 52 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 52 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 54 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 54 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 54 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 56 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 56 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 56 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 58 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 58 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 58 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 60 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 60 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 60 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 62 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 62 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 62 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 64 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 64 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 64 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 66 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 66 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 66 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 68 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 68 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 68 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 70 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 70 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 70 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 72 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 72 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 72 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 76 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 76 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 76 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 80 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 80 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 80 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 85 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 85 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 85 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 90 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 90 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 90 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 95 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 95 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 95 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 100 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 100 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 100 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 105 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 105 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 105 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 110 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 110 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 110 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 115 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 115 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 115 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 120 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 120 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 120 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 125 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 125 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 125 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 130 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 130 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 130 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 135 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 135 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 135 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 140 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 140 mm\nCortex Screw Ø 4.5 mm, self-tapp., L 140 mm","model_identifier":"02.164.000S\n02.164.001S\n02.164.002S\n02.164.003S\n02.164.004S\n02.164.005S\n02.164.006S\n02.164.007S\n02.200.010\n02.200.010S\n02.200.010TS\n02.200.012\n02.200.012S\n02.200.012TS\n02.200.014\n02.200.014S\n02.200.014TS\n02.200.016\n02.200.016S\n02.200.016TS\n02.200.018\n02.200.018S\n02.200.018TS\n02.200.020\n02.200.020S\n02.200.020TS\n02.200.022\n02.200.022S\n02.200.022TS\n02.200.024\n02.200.024S\n02.200.024TS\n02.200.026\n02.200.026S\n02.200.026TS\n02.200.028\n02.200.028S\n02.200.028TS\n02.200.030\n02.200.030S\n02.200.030TS\n02.200.032\n02.200.032S\n02.200.032TS\n02.200.034\n02.200.034S\n02.200.034TS\n02.200.036\n02.200.036S\n02.200.036TS\n02.200.038\n02.200.038S\n02.200.038TS\n02.200.040\n02.200.040S\n02.200.040TS\n02.200.042\n02.200.042S\n02.200.042TS\n02.200.044\n02.200.044S\n02.200.044TS\n02.200.045\n02.200.045S\n02.200.045TS\n02.200.046\n02.200.046S\n02.200.046TS\n02.200.048\n02.200.048S\n02.200.048TS\n02.200.050\n02.200.050S\n02.200.050TS\n02.200.055\n02.200.055S\n02.200.055TS\n02.200.060\n02.200.060S\n02.200.060TS\n02.200.065\n02.200.065S\n02.200.065TS\n02.200.070\n02.200.070S\n02.200.070TS\n02.200.075\n02.200.075S\n02.200.075TS\n02.200.080\n02.200.080S\n02.200.080TS\n02.200.085\n02.200.085S\n02.200.085TS\n02.200.090\n02.200.090S\n02.200.090TS\n02.200.095\n02.200.095S\n02.200.095TS\n02.200.100\n02.200.100S\n02.200.100TS\n02.200.105\n02.200.105S\n02.200.105TS\n02.200.110\n02.200.110S\n02.200.110TS\n02.200.115\n02.200.115S\n02.200.115TS\n02.200.120\n02.200.120S\n02.200.120TS\n02.200.125\n02.200.125S\n02.200.125TS\n02.200.130\n02.200.130S\n02.200.130TS\n02.200.135\n02.200.135S\n02.200.135TS\n02.200.140\n02.200.140S\n02.200.140TS\n02.200.145\n02.200.145S\n02.200.150\n02.200.150S\n02.206.210\n02.206.210S\n02.206.210TS\n02.206.212\n02.206.212S\n02.206.212TS\n02.206.214\n02.206.214S\n02.206.214TS\n02.206.216\n02.206.216S\n02.206.216TS\n02.206.218\n02.206.218S\n02.206.218TS\n02.206.220\n02.206.220S\n02.206.220TS\n02.206.222\n02.206.222S\n02.206.222TS\n02.206.224\n02.206.224S\n02.206.224TS\n02.206.226\n02.206.226S\n02.206.226TS\n02.206.228\n02.206.228S\n02.206.228TS\n02.206.230\n02.206.230S\n02.206.230TS\n02.206.232\n02.206.232S\n02.206.232TS\n02.206.234\n02.206.234S\n02.206.234TS\n02.206.236\n02.206.236S\n02.206.236TS\n02.206.238\n02.206.238S\n02.206.238TS\n02.206.240\n02.206.240S\n02.206.240TS\n02.206.242\n02.206.242S\n02.206.242TS\n02.206.244\n02.206.244S\n02.206.244TS\n02.206.245\n02.206.245S\n02.206.245TS\n02.206.246\n02.206.246S\n02.206.246TS\n02.206.248\n02.206.248S\n02.206.248TS\n02.206.250\n02.206.250S\n02.206.250TS\n02.206.252\n02.206.252S\n02.206.252TS\n02.206.254\n02.206.254S\n02.206.254TS\n02.206.256\n02.206.256S\n02.206.256TS\n02.206.258\n02.206.258S\n02.206.258TS\n02.206.260\n02.206.260S\n02.206.260TS\n03.164.000\n03.164.002\n03.164.004\n03.164.006\n03.164.008\n03.164.009\n03.164.010\n03.164.020\n03.164.020S\n03.164.021\n03.164.021S\n03.164.024\n03.164.025\n03.164.029\n03.164.029S\n03.164.030\n03.164.030S\n204.630\n204.630S\n204.630TS\n204.635\n204.635S\n204.635TS\n204.640\n204.640S\n204.640TS\n204.645\n204.645S\n204.645TS\n204.650\n204.650S\n204.650TS\n204.655\n204.655S\n204.655TS\n204.660\n204.660S\n204.660TS\n204.665\n204.665S\n204.665TS\n204.670\n204.670S\n204.670TS\n204.675\n204.675S\n204.675TS\n204.680\n204.680S\n204.680TS\n204.685\n204.685S\n204.685TS\n204.690\n204.690S\n204.690TS\n204.695\n204.695S\n204.695TS\n204.700\n204.700S\n204.700TS\n204.705\n204.705S\n204.705TS\n204.710\n204.710S\n204.710TS\n204.715\n204.715S\n204.715TS\n204.720\n204.720S\n204.720TS\n204.725\n204.725S\n204.725TS\n204.730\n204.730S\n204.730TS\n204.735\n204.735S\n204.735TS\n204.740\n204.740S\n204.740TS\n204.745\n204.745S\n204.750\n204.750S\n204.810\n204.810S\n204.812\n204.812S\n204.814\n204.814S\n204.816\n204.816S\n204.818\n204.818S\n204.820\n204.820S\n204.822\n204.822S\n204.824\n204.824S\n204.826\n204.826S\n204.828\n204.828S\n204.830\n204.830S\n204.832\n204.832S\n204.834\n204.834S\n204.836\n204.836S\n204.838\n204.838S\n204.840\n204.840S\n204.842\n204.842S\n204.844\n204.844S\n204.845\n204.845S\n204.846\n204.846S\n204.848\n204.848S\n204.850\n204.850S\n204.855\n204.855S\n204.860\n204.860S\n204.865\n204.865S\n204.870\n204.870S\n204.875\n204.875S\n204.880\n204.880S\n204.885\n204.885S\n204.890\n204.890S\n204.895\n204.895S\n204.900\n204.900S\n204.905\n204.905S\n204.910\n204.910S\n214.814\n214.814S\n214.814TS\n214.816\n214.816S\n214.816TS\n214.818\n214.818S\n214.818TS\n214.820\n214.820S\n214.820TS\n214.822\n214.822S\n214.822TS\n214.824\n214.824S\n214.824TS\n214.826\n214.826S\n214.826TS\n214.828\n214.828S\n214.828TS\n214.830\n214.830S\n214.830TS\n214.832\n214.832S\n214.832TS\n214.834\n214.834S\n214.834TS\n214.836\n214.836S\n214.836TS\n214.838\n214.838S\n214.838TS\n214.840\n214.840S\n214.840TS\n214.842\n214.842S\n214.842TS\n214.844\n214.844S\n214.844TS\n214.846\n214.846S\n214.846TS\n214.848\n214.848S\n214.848TS\n214.850\n214.850S\n214.850TS\n214.852\n214.852S\n214.852TS\n214.854\n214.854S\n214.854TS\n214.856\n214.856S\n214.856TS\n214.858\n214.858S\n214.858TS\n214.860\n214.860S\n214.860TS\n214.862\n214.862S\n214.862TS\n214.864\n214.864S\n214.864TS\n214.866\n214.866S\n214.866TS\n214.868\n214.868S\n214.868TS\n214.870\n214.870S\n214.870TS\n214.872\n214.872S\n214.872TS\n214.876\n214.876S\n214.876TS\n214.880\n214.880S\n214.880TS\n214.885\n214.885S\n214.885TS\n214.890\n214.890S\n214.890TS\n214.895\n214.895S\n214.895TS\n214.900\n214.900S\n214.900TS\n214.905\n214.905S\n214.905TS\n214.910\n214.910S\n214.910TS\n214.915\n214.915S\n214.915TS\n214.920\n214.920S\n214.920TS\n214.925\n214.925S\n214.925TS\n214.930\n214.930S\n214.930TS\n214.935\n214.935S\n214.935TS\n214.940\n214.940S\n214.940TS"},{"_id":86,"device_name":"FUJIFILM Fujifilm Endoscopy Support Program","description":"This software is intended to support the observer in interpreting and diagnosing the presence of a lesion by extracting the area that may be oesophageal squamous cell carcinoma or gastric neoplastic lesion in the endoscopic image of the upper gastrointestinal tract and displaying it to the observer of the image to draw the observer's attention to the possible lesion site. The purpose of this product is to “assist the observer in diagnosing the presence of a lesion” and is not intended to make a diagnosis of the presence of a lesion based solely on the detection results of this equipment.","gmdn_term":null,"medical_speciality_area":"Gastroenterology & Urology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251008E0007","registration_date":"8/10/2025 16:45","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"Fujifilm Corporation","product_owner_short_name":"Fujifilm Corporation","product_owner_address":"26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan","registrant_name":"FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD.","registrant_address":"10, NEW INDUSTRIAL ROAD, #-, FUJIFILM BUILDING, Singapore 536201","importer_name":"FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD.","importer_address":"10, NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, Singapore 536201","model_name":"Fujifilm Endoscopy Support Program","model_identifier":"EW10-EG01"},{"_id":87,"device_name":"Asus Ultrasound Imaging System","description":"The ASUS Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.","gmdn_term":null,"medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251008D0006","registration_date":"8/10/2025 10:42","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"ASUSTek Computer Inc.","product_owner_short_name":"ASUSTek Computer Inc.","product_owner_address":"1F, No.15, Lide Road, Beitou District,\nTaipei City, Taiwan R.O.C. , Taiwan","registrant_name":"EURO ASIA MEDICO PTE. LTD.","registrant_address":"6, TAGORE DRIVE, #04-13, TAGORE BUILDING, Singapore 787623","importer_name":null,"importer_address":null,"model_name":"ASUS Ultrasound Imaging System LU700C\nASUS Ultrasound Imaging System LU700L\nASUS MediConnect","model_identifier":"LU700C\nLU700L\nMediConnect"},{"_id":88,"device_name":"Arthrex Meniscal Dart™ Measuring Probe","description":"A hand-held manual instrument intended for manipulating tissue during an arthroscopic procedure. It may also be used as an accessory or used with other devices during the surgery.","gmdn_term":null,"medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251008C0005","registration_date":"8/10/2025 10:27","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"Arthrex, Inc.","product_owner_short_name":"Arthrex, Inc.","product_owner_address":"1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States","registrant_name":"ARTHREX SINGAPORE, PTE. LTD.","registrant_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","importer_name":"ARTHREX SINGAPORE, PTE. LTD.","importer_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","model_name":"Meniscal Dart™ Measuring Probe","model_identifier":"AR-4008"},{"_id":89,"device_name":"Arthrex Arthroscopic Measurement Probe","description":"A minimally invasive surgical instrument intended to determine the depth of a recess during medical procedures.","gmdn_term":null,"medical_speciality_area":"Orthopaedics","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251008B0004","registration_date":"8/10/2025 9:54","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"Arthrex, Inc.","product_owner_short_name":"Arthrex, Inc.","product_owner_address":"1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States","registrant_name":"ARTHREX SINGAPORE, PTE. LTD.","registrant_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","importer_name":"ARTHREX SINGAPORE, PTE. LTD.","importer_address":"Nucleous, 21 Biopolis Rd., #03-08, Singapore 138567","model_name":"Arthroscopic Measurement Probe, 60°, 220 mm","model_identifier":"AR-4070-01"},{"_id":90,"device_name":"Cochlear Cochlear Objective Measures","description":"The Cochlear Objective Measures software is intended to be used by hearing professionals both intra- and postoperatively to objectively verify the functioning and placement of a compatible Cochlear implant and the response of the recipient’s auditory system to electrical stimulation by the implant.","gmdn_term":"Cochlear implant intraoperative electrophysiological analysis software","medical_speciality_area":"Ear, Nose & Throat","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS C","device_registration_number":"MDPR251008A0003","registration_date":"8/10/2025 9:31","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"Cochlear Limited","product_owner_short_name":"Cochlear Limited","product_owner_address":"1 University Avenue, Macquarie University NSW 2109, Australia","registrant_name":"COCHLEAR LIMITED (Singapore Branch)","registrant_address":"238A, THOMSON ROAD, #25-06, NOVENA SQUARE, Singapore 307684","importer_name":"COCHLEAR LIMITED (Singapore Branch)","importer_address":"238A, THOMSON ROAD, #25-06, NOVENA SQUARE, Singapore 307684","model_name":"Cochlear Objective Measures","model_identifier":"P1986795"},{"_id":91,"device_name":"Merit Medical Pericardiocentesis Kit","description":"The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.","gmdn_term":"Pericardiocentesis catheter","medical_speciality_area":"Cardiovascular","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251008Z0002","registration_date":"8/10/2025 7:45","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"MERIT MEDICAL SYSTEMS INC","product_owner_short_name":"MERIT MEDICAL SYSTEMS INC","product_owner_address":"1600 WEST MERIT PARKWAY, SOUTH JORDAN, UTAH 84095, United States","registrant_name":"MERIT MEDICAL SINGAPORE PTE. LTD.","registrant_address":"10, COLLYER QUAY, #10-01, OCEAN FINANCIAL CENTRE, Singapore 049315","importer_name":"AXTRA DEVICES PTE. LTD.; MERIT MEDICAL SINGAPORE PTE. LTD.","importer_address":"198, YISHUN AVENUE 7, Singapore 768926; 22, SIN MING LANE, #06-76, MIDVIEW CITY, Singapore 573969","model_name":"Merit Medical Pericardiocentesis Kit\nMerit Medical Pericardiocentesis Kit","model_identifier":"PC101\nPC801"},{"_id":92,"device_name":"IRIS IRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens","description":"IRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is indicated for the correction of refractive error in aphakic and not aphakic persons with non-disease eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.","gmdn_term":"Soft corrective contact lens, daily-disposable","medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251008Y0001","registration_date":"8/10/2025 7:42","change_notification_approval_date":null,"retention_due_date":"7/10/2026 0:00","product_owner_name":"IRIS (Xiamen) Science Co., Ltd.","product_owner_short_name":"IRIS (Xiamen) Science Co., Ltd.","product_owner_address":"No. 39 Yinlu Avenue, Tong’an District, Xiamen, Fujian, China","registrant_name":"ALCOTECH PTE. LTD.","registrant_address":"25, BUKIT BATOK CRESCENT, #09-13, THE ELITIST, Singapore 658066","importer_name":"ALCOTECH PTE. LTD.","importer_address":"25, BUKIT BATOK CRESCENT, #09-13, THE ELITIST, Singapore 658066","model_name":"IRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of 1, 2, 3, 5, 6, 10, 12, 15, 16, 20, 30 blister(s) in secondary packaging\nIRIS Color 55 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens\nbetween -0.25D and -10.00D, inclusive of -10.00D \nBase curve: 8.20 mm to 9.00 mm\nDiameter: 13.00 mm to 14.50 mm\nPack of ","model_identifier":"BL-101(Black)\nBL-102(Brown)\nBL-103(Grey)\nBL-104(Violet)\nBL-105(Blue)\nBL-106(Orange)\nBL-107(Golden)\nBL-108(Green)\nBL-109(Pink)\nBL-110(Golden)\nBL-111(Silver)\nCT-201(Black)\nCT-202(Brown)\nCT-203(Grey)\nCT-204(Violet)\nCT-205(Blue)\nCT-206(Orange)\nCT-207(Golden)\nFLY-201(Brown)\nFLY-202(Golden)\nFLY-203(Grey)\nFLY-204(Golden)\nFLY-205(Violet)\nFLY-206(Blue)\nFLY-210(Black)\nFLY-212(Brown)\nFLY-215(Pink)\nHB1-301(Brown)\nHD1-201(Black)\nHD1-202(Brown)\nHD1-301(Pink)\nHD1-302(Blue)\nHD1-303(Violet)\nHD1-304(Brown)\nHD1-305(Green)\nHD1-306(Brown)\nHD1-307(Grey)\nHD1-308(Grey)\nHD1-309(Brown)\nHD1-310(Pink)\nHD2-201(Orange)\nHD2-202(Blue)\nHD2-203(Grey)\nHD2-204(Grey)\nHD2-205(Brown)\nHD2-301(Blue)\nHD2-302(Brown)\nHD2-303(Green)\nHD2-304(Blue)\nHD2-305(Brown)\nHD2-306(Brown)\nHD2-307(Grey)\nHD3-301(Grey)\nHD3-302(Brown)\nHD3-303(Black)\nHD3-304(Black)\nHD3-305(Pink)\nHD3-306(Brown)\nHD3-307(Grey)\nHD3-308(Blue)\nHD3-309(Pink)\nHD3-310(Grey)\nHD3-311(Brown)\nID1-201(Brown)\nID1-202(Brown)\nID1-203(Violet)\nID1-301(Violet)\nID1-302(Brown)\nID1-303(Blue)\nID2-201(Brown)\nID2-202(Green)\nID2-301(Golden)\nID2-302(Brown)\nID2-303(Brown)\nID2-304(Grey)\nID2-305(Brown)\nID2-306(Pink)\nID3-201(Pink)\nID3-301(Pink)\nID3-302(Green)\nID3-303(Blue)\nID3-304(Brown)\nID3-305(Blue)\nID3-306(Brown)\nID3-307(Pink)\nID4-301(Blue)\nID4-302(Pink)\nID4-303(Blue)\nID4-304(Green)\nID4-305(Violet)\nID4-306(Violet)\nID4-307(Green)\nID4-308(Grey)\nID5-301(Green)\nID5-302(Green)\nID5-303(Pink)\nID5-304(Blue)\nID5-305(Violet)\nID5-306(Blue)\nID5-307(Green)\nID5-308(Pink)\nID6-301(Grey)\nID6-302(Brown)\nID6-303(Grey)\nID6-304(Green)\nID6-305(Grey)\nID6-306(Grey)\nID6-307(Grey)\nID6-308(Brown)\nID7-301(Blue)\nID7-302(Brown)\nID7-303(Grey)\nID7-304(Pink)\nID7-305(Green)\nID7-306(Blue)\nID7-307(Blue)\nID8-301(Green)\nID8-302(Pink)\nID8-303(Pink)\nID8-304(Green)\nID8-305(Blue)\nKJ1-301(Grey)\nKN1-301(Grey)\nKN1-302(Grey)\nKS1-301(Brown)\nKS1-302(Black)\nKS1-303(Grey)\nKS1-304(Brown)\nLR-101(Black)\nLR-102(Brown)\nLR-201(Grey)\nLR-202(Green)\nLR-203(Golden)\nLR-204(Violet)\nLR-205(Blue)\nMB1-201(Brown)\nMB1-202(Pink)\nMB1-203(Blue)\nMB1-301(Black)\nMB1-302(Brown)\nMB1-303(Brown)\nMB1-304(Golden)\nMB1-305(Brown)\nMB1-306(Brown)\nMB1-307(Brown)\nMB1-308(Brown)\nMB1-309(Brown)\nMB1-310(Pink)\nMB1-311(Grey)\nMB1-312(Pink)\nMB1-313(Blue)\nMB1-314(Brown)\nMB1-315(Blue)\nMB1-316(Blue)\nMB1-317(Green)\nMB1-318(Blue)\nMB1-319(Pink)\nMH1-201(Brown)\nMH1-202(Grey)\nMH1-301(Black)\nMH1-302(Brown)\nMH1-303(Brown)\nMH1-304(Green)\nMH1-305(Grey)\nMH1-306(Brown)\nML1-301(Brown)\nML1-302(Blue)\nML1-303(Pink)\nML1-304(Pink)\nML1-305(Pink)\nMM1-201(Black)\nMM1-301(Brown)\nMM1-302(Grey)\nMM1-303(Brown)\nmoody, ACCELERADO\nmoody, AMBER BROWN\nmoody, AUTUMN NOCTURNE\nmoody, BLACK RAVEN\nmoody, BLING BLING\nmoody, BOP ZIWEI\nmoody, BRAMBLES\nmoody, BREEZE\nmoody, BUBBLE NEBULA\nmoody, BUBBLY SUNSET\nmoody, CAMELLIA BROWN\nmoody, CANDLELIGHT WALTZ\nmoody, CAREFREE SUMMER\nmoody, CHILL BLUE\nmoody, CLOUDY ENLARGE\nmoody, CLOUDY MELODY\nmoody, COCO BROWN\nmoody, COCOA GLEAM\nmoody, COCOON\nmoody, COLDSMOKE ISLES\nmoody, CUP OF TEA\nmoody, CUTE BABE\nmoody, DARK NIGHTINGALE\nmoody, DOWNTEMPO COMET\nmoody, DUSTY LAKE\nmoody, DUSTY PEACH\nmoody, FATE\nmoody, FOAMY ENLARGE\nmoody, FRESH BROWN\nmoody, FUSE\nmoody, GEMINI BLUES\nmoody, GLAZE HALO\nmoody, GOLDEN MEMORY\nmoody, GRAVITY VINYL\nmoody, HALF DREAM LOTUS\nmoody, HAPPY XIAOXIN\nmoody, HAZED HAVEN\nmoody, HOLIDAY BLUES\nmoody, INDIGO FLANNEL\nmoody, IRIS NEBULA\nmoody, ISLAND HALO\nmoody, JAZZ LIGHTYEAR\nmoody, LADY NINI\nmoody, LAZY BROWN\nmoody, MAGIC MIRROR\nmoody, MENTA ROSE\nmoody, METEOR FUNK\nmoody, MIRROR GRAY\nmoody, MIRROR MIRROR\nmoody, MIST GREEN\nmoody, MISTY ROSES\nmoody, MOON FISHTAIL\nmoody, NICE DAY BROWN & FRIENDS\nmoody, OCEAN EXPRESS\nmoody, Oolong Brown\nmoody, PEARL BLACK\nmoody, PEARL GREY\nmoody, PICTURE PERFECT\nmoody, PINEWOOD CABIN\nmoody, POLAR DAY\nmoody, POLAR PUNK\nmoody, PUMPKIN SILKY\nmoody, PUPPY BROWN\nmoody, RALLENDANDO\nmoody, SANDSTORM\nmoody, SMOOTH PINE\nmoody, SOFT BROWN\nmoody, SOULTONE BUBBLES\nmoody, SPACE GLITTER BALL\nmoody, SPRINGTIME\nmoody, STAR WALK\nmoody, STARDEW ROMANCE\nmoody, STARTRAILS PARTY\nmoody, SUNNY BLOOM\nmoody, SWAYING EUSTOMA\nmoody, SWING\nmoody, TENDER BROWN\nmoody, TIPSY FIG\nmoody, TROPICAL BLUE\nmoody, UNDERCURRENT\nmoody, VELVET FOGGY\nmoody, VELVETEEN BLACK\nmoody, VERY PERI\nmoody, WEIGHTLESS SOLO\nmoody, WHIRLWIND\nmoody, WILD SHADOW\nmoody, Wisterias Grey\nmoody,TEA BROWN\nMOODYBLUE, moodyblue\nMS1-201(Brown)\nMS1-301(Pink)\nMS1-302(Blue)\nMS1-303(Brown)\nMS1-304(Pink)\nMS1-305(Brown)\nMS1-306(Black)\nMS1-307(Grey)\nMS1-308(Brown)\nMS1-309(Blue)\nMS2-301(Black)\nMS2-302(Grey)\nMS2-303(Brown)\nMS2-304(Blue)\nMS2-305(Brown)\nMS2-306(Pink)\nMS3-201(Black)\nMS3-301(Pink)\nMS3-302(Grey)\nMS3-303(Blue)\nMS3-304(Brown)\nNANODOTS, B-beiguo\nNANODOTS, B-coco\nNANODOTS, B-dasha\nNANODOTS, B-huasheng\nNANODOTS, B-popcorn\nNANODOTS, G-tangyuan\nNANODOTS, G-xingxing\nNANODOTS, G-zhima\nNANODOTS, L-bale\nNANODOTS, O-heika\nNANODOTS, P-xiangwo\nNANODOTS, R-pingfang\nNANODOTS, R-pingguo\nNANODOTS, R-shumei\nNANODOTS, U-buding\nNANODOTS, U-dipian\nNANODOTS, U-jiangguo\nNANODOTS, U-qiqiu\nNANODOTS,P-tang\nNB1-201(Brown)\nNB1-202(Black)\nPL-301(Golden)\nRC1-301(Green)\nRC1-302(Grey)\nRC1-303(Blue)\nRC1-304(Orange)\nRC1-305(Violet)\nRC1-306(Golden)\nRC2-001(Mix)\nRC2-301(Blue)\nRC2-302(Green)\nRC2-303(Golden)\nRC2-304(Grey)\nRC2-305(Violet)\nRC2-306(Orange)\nRC2-308(Brown)\nRC2-309(Black)\nRC2-310(Golden)\nRC2-311(Silver)\nRC2-312(Pink)\nRC3-201(Blue)\nRC3-202(Grey)\nRC3-203(Green)\nRC3-204(Orange)\nRC3-205(Violet)\nRC3-206(Golden)\nRO-101(Black)\nRO-102(Brown)\nRO-201(Brown)\nRO-202(Grey)\nS-207(Golden)\nS-209(Violet)\nS-210(Green)\nS-211(Blue)\nS-212(Orange)\nS1-201(Black)\nS1-202(Brown)\nS1-203(Grey)\nSB1-201(Grey)\nSB1-301(Brown)\nSB1-302(Brown)\nSB1-303(Brown)\nSB1-304(Brown)\nSB1-305(Grey)\nSK-201(Black)\nSK-202(Brown)\nSK-203(Grey)\nSK-204(Golden)\nSK-205(Blue)\nSK-206(Violet)\nSK-207(Brown)\nSL-201(Black)\nSL-202(Brown)\nSL-203(Grey)\nSL-204(Blue)\nSL-205(Violet)\nSL-206(Golden)\nSL-207(Orange)\nSP-202(Orange)\nSP-204(Brown)\nSP-206(Grey)\nSP-207(Blue)\nSP-209(Violet)\nSP-211(Golden)\nSP1-201(Black)\nSP1-301(Blue)\nSP1-302(Brown)\nSP1-303(Brown)\nSP1-304(Brown)\nSP1-305(Golden)\nSP1-306(Grey)\nST-201(Black)\nST-202(Brown)\nST-203(Blue)\nST-204(Grey)\nST-205(Golden)\nST-206(Violet)\nST-207(Golden)\nST-208(Silver)\nST1-301(Pink)\nST1-302(Brown)\nST1-303(Blue)\nST1-304(Pink)\nTN-201(Black)\nTN-202(Brown)\nTN-203(Blue)\nTN-204(Golden)\nTN-205(Violet)\nTN-206(Orange)\nTR-101(Black)\nTR-102(Brown)\nTR-201(Golden)\nTR-202(Grey)\nTR-203(Blue)\nTR-204(Violet)\nTR-205(Green)\nTR-206(Brown)"},{"_id":93,"device_name":"PPM Medical CVC Set","description":"Collection of Various surgical instruments, dressings and the necessary materials to perform a general-purpose surgical procedure.it does not contain pharmaceuticals. This is a single-use device","gmdn_term":null,"medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251007E0008","registration_date":"7/10/2025 17:23","change_notification_approval_date":null,"retention_due_date":"6/10/2026 0:00","product_owner_name":"PPM Medical Pte Ltd","product_owner_short_name":"PPM Medical Pte Ltd","product_owner_address":"2, BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554","registrant_name":"PPM MEDICAL PTE. LTD.","registrant_address":"2, BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554","importer_name":"PPM MEDICAL PTE. LTD.","importer_address":"2, BUKIT BATOK STREET 23, #08-05, BUKIT BATOK CONNECTION, Singapore 659554","model_name":"CVC Set","model_identifier":"10-081"},{"_id":94,"device_name":"Centrix FluoroDose 5% Sodium Fluoride Varnish","description":"Dentin desensitizer","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251007C0006","registration_date":"7/10/2025 15:35","change_notification_approval_date":null,"retention_due_date":"6/10/2026 0:00","product_owner_name":"Centrix Incorporated","product_owner_short_name":"Centrix Incorporated","product_owner_address":"770 River Road, Shelton, Connecticut 06484, United States","registrant_name":"ADM ASIA-PACIFIC PTE. LTD.","registrant_address":"387, JOO CHIAT ROAD, #03-04, THE MODULES, Singapore 427623","importer_name":"ADM ASIA-PACIFIC PTE. LTD.","importer_address":"387, JOO CHIAT ROAD, #03-04, MODULES, THE, Singapore 427623","model_name":"FluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol\nFluoroDose 5% Sodium Fluoride Varnish with Xylitol","model_identifier":"310026\n310027\n310028\n310029\n310030\n360077\n360078\n360079\n360086\n360087\n360105\n360106\n360107\n360108\n360109\n360110\n360111\n360112\n360137\n360138\n360139\n360140\n360141\n360142\n360143\n700001\n870039"},{"_id":95,"device_name":"Asiga DentaTOOTH","description":"Asiga DentaTOOTH is intended exclusively for professional dental work. \n\nAsiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers to temporarily restore and protect damaged tooth/teeth while a permanent restoration is being prepared. \nTemporary crowns, bridges, inlays, onlays and veneers are intended to be removed in less than 30 days. \n\nAsiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed denture teeth. The denture teeth produced are suitable for dental indications including removable dentures for edentulous patients. ","gmdn_term":null,"medical_speciality_area":"Dental","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251007B0005","registration_date":"7/10/2025 15:03","change_notification_approval_date":null,"retention_due_date":"6/10/2026 0:00","product_owner_name":"Asiga Pty Ltd","product_owner_short_name":"Asiga Pty Ltd","product_owner_address":"Unit 2, 19-21 Bourke Rd, Alexandria, New South Wales 2015, Australia","registrant_name":"QUALTECH CONSULTING CORPORATION PTE. LTD.","registrant_address":"111, NORTH BRIDGE ROAD, #21-01, PENINSULA PLAZA, Singapore 179098","importer_name":null,"importer_address":null,"model_name":"DentaTOOTH\nDentaTOOTH\nDentaTOOTH\nDentaTOOTH\nDentaTOOTH\nDentaTOOTH","model_identifier":"03624-A1\n03625-A2\n03626-A3\n03810-B1\n03812-B2\n03814-B3"},{"_id":96,"device_name":"Hangzhou Mindray Mindray Disposable Electrode Surgical Instruments","description":"For grasping, dissecting and bipolar coagulating tissue or organ in laparoscopic surgery.","gmdn_term":"Endoscopic electrosurgical electrode, bipolar, single-use","medical_speciality_area":"General Hospital","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251007A0004","registration_date":"7/10/2025 13:12","change_notification_approval_date":null,"retention_due_date":"6/10/2026 0:00","product_owner_name":"Hangzhou Mindray Medical Technology Co.,Ltd","product_owner_short_name":"Hangzhou Mindray Medical Technology Co.,Ltd","product_owner_address":"No.2 Fengxian Road, Economic Development Zone, Tonglu, Hangzhou, Zhejiang 311508, Hangzhou, Zhejing, China","registrant_name":"HEALTHCARE ESSENTIALS PTE. LTD.","registrant_address":"1023, YISHUN INDUSTRIAL PARK A, #02-19, YISHUN INDUSTRIAL PARK A, Singapore 768762","importer_name":"HEALTHCARE ESSENTIALS PTE. LTD.","importer_address":"1023, YISHUN INDUSTRIAL PARK A, #02-19, YISHUN INDUSTRIAL PARK A, Singapore 768762","model_name":"DISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS\nDISPOSABLE ELECTRODE SURGICAL INSTRUMENTS","model_identifier":"BAA33\nBAA33E\nBAA36\nBAA36E\nBAA45\nBAA45E\nBAB33\nBAB33E\nBAB36\nBAB36E\nBAB45\nBAB45E\nBAC33\nBAC33E\nBAC36\nBAC36E\nBAC45\nBAC45E\nBAD33\nBAD36\nBAD45\nBDA33\nBDA33E\nBDA36\nBDA36E\nBDA45\nBDA45E\nBDB33\nBDB33E\nBDB36\nBDB36E\nBDB45\nBDB45E\nBDC33\nBDC33E\nBDC36\nBDC36E\nBDC45\nBDC45E\nBDD33\nBDD36\nBDD45\nBFA33\nBFA33E\nBFA36\nBFA36E\nBFA45\nBFA45E\nBFB33\nBFB33E\nBFB36\nBFB36E\nBFB45\nBFB45E\nBFC33\nBFC33E\nBFC36\nBFC36E\nBFC45\nBFC45E\nBFD33\nBFD36\nBFD45"},{"_id":97,"device_name":"Healgen Scientific Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test","description":"The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.\n\nAll negative results are presumptive and should be confirmed with a molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza and SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should therefore seek follow-up care from their healthcare provider.\n\nPositive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.","gmdn_term":"SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical; Influenza A/B virus antigen IVD, kit, rapid ICT, clinical","medical_speciality_area":"Microbiology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS D","device_registration_number":"MDPR251007Z0003","registration_date":"7/10/2025 13:11","change_notification_approval_date":"24/10/2025 12:06","retention_due_date":"6/10/2026 0:00","product_owner_name":"Healgen Scientific Limited Liability Company","product_owner_short_name":"Healgen Scientific Limited Liability Company","product_owner_address":"3818 Fuqua Street, Houston TX 77047, United States","registrant_name":"ALCOTECH PTE. LTD.","registrant_address":"25, BUKIT BATOK CRESCENT, #09-13, THE ELITIST, Singapore 658066","importer_name":"ALCOTECH PTE. LTD.","importer_address":"25, BUKIT BATOK CRESCENT, #09-13, THE ELITIST, Singapore 658066","model_name":"Healgen Rapid Check COVID-19/Flu A&B Antigen Test\nHealgen Rapid Check COVID-19/Flu A&B Antigen Test\nHealgen Rapid Check COVID-19/Flu A&B Antigen Test\nHealgen Rapid Check COVID-19/Flu A&B Antigen Test\nHealgen Rapid Check COVID-19/Flu A&B Antigen Test\nHealgen Rapid Check COVID-19/Flu A&B Antigen Test\nHealgen Rapid Check COVID-19/Flu A&B Antigen Test","model_identifier":"GCFC-525SKa-H1\nGCFC-525SKa-H2\nGCFC-525SKa-H20\nGCFC-525SKa-H25\nGCFC-525SKa-H3\nGCFC-525SKa-H4\nGCFC-525SKa-H5"},{"_id":98,"device_name":"Happi 1Day Disposable Silicone Hydrogel Contact Lens","description":"Happi 1Day Disposable is a hydrophilic silicone hydrogel soft contact lens which is available as a spherical lens, and intended for the correction of refractive ametropia in non-diseased eyes.\nThis soft contact lens is a sterilized silicone hydrogel contact lens with 56% water content, and indicated for the optical correction of refractive ametropia (myopia and hyperopia) in non-aphakic persons with non-diseased eyes who may have 1.50D.","gmdn_term":null,"medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251007Y0002","registration_date":"7/10/2025 9:53","change_notification_approval_date":null,"retention_due_date":"6/10/2026 0:00","product_owner_name":"Menicon Co. Ltd","product_owner_short_name":"Menicon Co. Ltd","product_owner_address":"3-21-19, Aoi, Naka-ku, Nagoya, 460-0006, Japan","registrant_name":"Menicon Singapore Sales PTE. LTD.","registrant_address":"38, Jalan Pemimpin, #06-06, M38, Singapore 577178","importer_name":null,"importer_address":null,"model_name":"Happi 1Day Disposable\nSilicone Hydrogel Contact Lens","model_identifier":"30 lenses box"},{"_id":99,"device_name":"Happi 1Day Disposable Toric Silicon Hydrogel Contact Lens","description":"Happi 1Day Disposable Toric is a hydrophilic silicone hydrogel soft contact lens which is available as a toric lens, and indicated for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in non-aphakic persons with non-diseased eyes with 3.00D or less of refractive astigmatism.","gmdn_term":null,"medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251007X0001","registration_date":"7/10/2025 9:27","change_notification_approval_date":null,"retention_due_date":"6/10/2026 0:00","product_owner_name":"Menicon Co. Ltd","product_owner_short_name":"Menicon Co. Ltd","product_owner_address":"3-21-19, Aoi, Naka-ku, Nagoya, 460-0006, Japan","registrant_name":"Menicon Singapore Sales PTE. LTD.","registrant_address":"38, Jalan Pemimpin, #06-06, M38, Singapore 577178","importer_name":null,"importer_address":null,"model_name":"Happi 1Day Disposable Toric Silicon Hydrogel Contact Lens","model_identifier":"30 lenses box"},{"_id":100,"device_name":"AJL CELL Viscoelastic Solution","description":"AJL CELL is indicated as an adjuvant in surgical procedures of the anterior segment of the eye, including cataract surgery and intraocular lens implantation. It can fulfill two functions: \n- Lubricate the foldable intraocular lenses in the injector cartridges. \n- Maintain the depth of the anterior chamber during the intervention. This provides high tissue protection, while avoiding the risk of trauma to the corneal endothelium and other ocular tissues","gmdn_term":"Vitreous/aqueous humour replacement medium, intraoperative","medical_speciality_area":"Ophthalmology","hs_code":null,"hsa_product_code":null,"medical_device_class":"CLASS B","device_registration_number":"MDPR251006C0007","registration_date":"6/10/2025 17:31","change_notification_approval_date":null,"retention_due_date":"5/10/2026 0:00","product_owner_name":"AJL OPHTHALMIC SA","product_owner_short_name":"AJL OPHTHALMIC SA","product_owner_address":"AJL Ophthalmic SA, Parque Tecnológico de Álava,, Ferdinand Zeppelin 1,, Miňano, Alava 01510, MINANO MAYOR, MINANO, ALAVA, Spain","registrant_name":"AVENTISIN PTE. LTD.","registrant_address":", 50 raffles place, #30-85, singapore land tower, Singapore 048623","importer_name":"AVENTISIN PTE. LTD.","importer_address":", 50 raffles place, #30-85, singapore land tower, Singapore 048623","model_name":"AJL CELL Viscoelastic Solutions","model_identifier":"AJL CELL 2%"}],"_links":{"start":"/api/action/datastore_search?resource_id=d_8cfe111e0a5a5cf5b598e78851e58ad4","next":"/api/action/datastore_search?resource_id=d_8cfe111e0a5a5cf5b598e78851e58ad4&offset=100"},"total":20599}}