Medical Device Division · registration 140080Expired

Edwards Lifesciences

Name: Edwards Lifesciences — Medical Device Division 140080
Creator: Edwards Lifesciences LLC
Keywords: Edwards Lifesciences, Edwards Lifesciences, 140080, Prostheses, Cardiac Valve, Biological, Medical Device Division

Hong KongProstheses, Cardiac Valve, BiologicalClass IVEdwards Lifesciences LLC

Verified

Official record identity

MDACS listing number: 140080
Model name: Edwards SAPIEN XT Transcatheter Heart Valve (9300TFX), NovaFlex+ Delivery System (9355FS20, 9355FS23, 9355FS26, 9355FS29), Edwards Expandable Introducer Sheath Set (916ES23, 918ES26, 920ES29), RetroFlex Dilator Kit (9100DKS), Edwards Transfemoral Balloon Catheter (9350BC16, 9350BC20, 9350BC23, 9350BC25), Crimper (9350CR), Atrion QL Inflation Device (96402),Atrion QL Locking Syringe Device (96406), Ascendra+ Delivery System (9355AS23, 9355AS26,9355AS29), Ascendra+ Introducer Sheath Set (9350IS23, 9350IS26, 9350IS29), Ascendra Balloon Aortic Valvuloplasty Catheter (9100BAVC)
Registration date: November 09, 2017
Expiry date: March 17, 2019
Source update date: May 29, 2018
Status: Expired

Classification

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

Published parties

Registrant / registration holder: DCH Auriga (Hong Kong) Limited
Manufacturer: Edwards Lifesciences LLC

Official description

Prostheses, Cardiac Valve, Biological

Additional source fields

AMD nomenclature code: 15870
Traditional Chinese local responsible person: 奧利佳(香港)有限公司
Local responsible person phone: 36192800
Published manufacturer address: One Edwards Way, Irvine, CA 92614, USA
Published remarks: Expired.
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.