Medical Device Division · registration 220151ActiveEdwards Lifesciences
Hong KongProstheses, Cardiac Valve, BiologicalClass IVEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 220151
- Model name
- MITRIS RESILIA Mitral Valve 11400M (11400M25, 11400M27, 11400M29, 11400M31, 11400M33)
- Registration date
- August 29, 2023
- Expiry date
- May 16, 2027
- 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
- a
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.