140080
IV
Expired.
Prostheses, Cardiac Valve, Biological假体, 心脏瓣膜, 生物
This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve, Biological. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Prostheses, Cardiac Valve, Biological
產品資訊： 假体, 心脏瓣膜, 生物
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
15870
Product Code Detail
15870 Prostheses, Cardiac Valve, Biological
State
Expired.
Status
N/A
Manufacturer (製造商)
Edwards Lifesciences LLC
Edwards Lifesciences
United States
美国
One Edwards Way, Irvine, CA 92614, USA
爱德华兹路一号,尔湾,CA 92614,美国
Authorised Representative (AR)
DCH Auriga (Hong Kong) Limited
奥利佳(香港)有限公司
36192800
Regulatory Timeline
Registration Date
November 09, 2017
Expiry Date
March 17, 2019
Product Models
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)
Edwards SAPIEN XT 经导管心脏瓣膜 (9300TFX)、NovaFlex+ 输送系统(9355FS20、9355FS23、9355FS26、9355FS29)、Edwards 可扩展导引器护套套件(916ES23、918ES26、920ES29)、RetroFlex 扩张器套件 (9100DKS)、Edwards 经股动脉球囊导管(9350BC16、9350BC20、9350BC23、9350BC25)、压接器 (9350CR)、Atrion QL 充气装置 (96402)、Atrion QL 锁定注射器装置 (96406)、Ascendra+ 输送系统 (9355AS23、9355AS26、) 9355AS29),Ascendra+ 导引器护套套装 (9350IS23, 9350IS26、9350IS29)、Ascendra 球囊主动脉瓣成形术导管 (9100BAVC)