Medical Device Division · registration 140080ExpiredEdwards Lifesciences
Hong KongProstheses, Cardiac Valve, BiologicalClass IVEdwards Lifesciences LLC
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
Official value: IV
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.