Medical Device Division · registration 180111Active

Edwards Lifesciences

Name: Edwards Lifesciences — Medical Device Division 180111
Creator: Edwards Lifesciences LLC
Keywords: Edwards Lifesciences, Edwards Lifesciences, 180111, Prostheses, Cardiac Valve, Biological, Medical Device Division

Hong KongProstheses, Cardiac Valve, BiologicalClass IVEdwards Lifesciences LLC

Verified

Official record identity

MDACS listing number: 180111
Model name: Carpentier Edwards Perimount Magna Ease Pericardial Bioprosthesis (3300TFX19MM, 3300TFX21MM, 3300TFX23MM, 3300TFX25MM, 3300TFX27MM, 3300TFX29MM), Carpentier Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis (7300TFX25, 7300TFX27, 7300TFX29, 7300TFX31, 7300TFX33)
Registration date: January 23, 2025
Expiry date: May 04, 2028
Source update date: April 25, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Prostheses, Cardiac Valve, Biological

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: c

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.