Medical Device Division · registration 110262ActiveEdwards Lifesciences
Hong KongAnnuloplasty Ring/Band ImplantsClass IVEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 110262
- Model name
- Carpentier-Edwards Physio Annuloplasty Ring with Holder (4450), Carpentier-Edwards Physio II Annuloplasty Ring (5200)
- Registration date
- April 29, 2026
- Expiry date
- September 08, 2031
- 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
Annuloplasty Ring/Band Implants
Additional source fields
- AMD nomenclature code
- 16039
- Local responsible person phone
- 31809428
- Published manufacturer address
- One Edwards Way, Irvine, CA 92614, USA
- Revision number
- g
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.