Prostheses, Cardiac Valve, Biological

假体, 心脏瓣膜, 生物

Edwards Lifesciences LLC·IV·Hong Kong MDACS·Registered December 06, 2023

Device overview

Risk class: IV
Product code: 15870
State: current
Status: N/A
Product code detail: 15870 Prostheses, Cardiac Valve, Biological

Manufacturer (製造商)

Name: Edwards Lifesciences LLC
Edwards Lifesciences
Country: United States
美国
Address: One Edwards Way, Irvine CA 92614, United States Of America
爱德华兹路一号, 尔湾 CA 92614, 美国

Authorised representative (AR)

Name: Edwards Lifesciences Hong Kong Limited
Phone: 31809428/36192691

Regulatory timeline

Registration date: December 06, 2023
Expiry date: December 06, 2028

Product models

INSPIRIS RESILIA Aortic Valve (Sizes 19, 21, 23, 25, 27 and 29 mm) (11500A)

肌螺旋体主动脉瓣(尺寸 19、21、23、25、27 和 29 mm)(11500A)

About this record

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