190198
IV
current
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This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve, Biological. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Prostheses, Cardiac Valve, Biological
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
15870
Product Code Detail
15870 Prostheses, Cardiac Valve, Biological
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Edwards Lifesciences LLC
Edwards Lifesciences
United States
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One Edwards Way, Irvine, CA 92614, USA
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Authorised Representative (AR)
31809428/36192691
Regulatory Timeline
Registration Date
July 16, 2024
Expiry Date
July 15, 2029
Product Models
Edwards SAPIEN 3-Edwards Commander Kit (S3TF120, S3TF123, S3TF126, S3TF129), Edwards SAPIEN 3-Edwards Certitude Kit (S3TA120, S3TA123, S3TA126, S3TA129), SAPIEN 3 Transcatheter Heart Valve (9600TFX), Edwards eSheath Introducer Set (9610ES14, 9610ES16), Edwards Commander Delivery System ( 9610TF20, 9610TF23, 9610TF26, 9610TF29), Edwards Transfemoral Balloon Catheter (9350BC16, 9350BC20, 9350BC23, 9350BC25 ), Crimper (9600CR), QL2530 Inflation Device (96402), QL38 Locking Syringe (96406), Edwards Certitude Introducer Sheath Set (9620IS18, 9620IS21), Edwards Certitude Delivery System (9620TA20, 9620TA23, 9620TA26, 9620TA29), Ascendra Balloon Aortic Valvuloplasty Catheter (9100BAVC)
Edwards SAPIEN 3-Edwards Commander ๅฅไปถ(S3TF120ใS3TF123ใS3TF126ใS3TF129)ใEdwards SAPIEN 3-Edwards Certitude ๅฅไปถ(S3TA120ใS3TA123ใS3TA126ใS3TA129)ใSAPIEN 3 ็ปๅฏผ็ฎกๅฟ่็ฃ่ (9600TFX)ใEdwards ๆคๅฅๅฏผๅผๅจๅฅไปถ(9610ES14ใ9610ES16)ใEdwards Commander Delivery ็ณป็ป ( 9610TF20, 9610TF23, 9610TF26, 9610TF29), Edwards ็ป่ก็ๅๅฏผ็ฎก (9350BC16, 9350BC20, 9350BC23, 9350BC25 ), ๅๆฅๅจ (9600CR), QL2530 ๅ
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็ฝฎ (96402), QL38 ้ๅฎๆณจๅฐๅจ (96406), Edwards Certitude ๅฏผๅผๅจ้ๅฅไปถ (9620IS18ใ9620IS21)ใEdwards Certitude ่พ้็ณป็ป(9620TA20ใ9620TA23ใ9620TA26ใ9620TA29)ใAscendra ็ๅไธปๅจ่็ฃๆๅฝขๆฏๅฏผ็ฎก (9100BAVC)