Medical Device Division · registration 180503ActiveEdwards Lifesciences
Hong KongProstheses, Cardiac Valve, BiologicalClass IVEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 180503
- Model name
- INSPIRIS RESILIA Aortic Valve (Sizes 19, 21, 23, 25, 27 and 29 mm) (11500A)
- Registration date
- December 06, 2023
- Expiry date
- December 06, 2028
- Source update date
- December 30, 2025
- 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, United States Of America
- 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.