Medical Device Division · registration 190198ActiveEdwards Lifesciences
Hong KongProstheses, Cardiac Valve, BiologicalClass IVEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 190198
- Model name
- 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)
- Registration date
- July 16, 2024
- Expiry date
- July 15, 2029
- Source update date
- April 25, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Edwards Lifesciences Hong Kong Limited
- Manufacturer
- Edwards Lifesciences LLC
Official description
Prostheses, Cardiac Valve, Biological
Additional source fields
- AMD nomenclature code
- 15870
- Local responsible person phone
- 31809428
- Published manufacturer address
- One Edwards Way, Irvine, CA 92614, USA
- Revision number
- b
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.