Pure Global
190233

Prostheses, Cardiac Valve, Biological

假体, 心脏瓣膜, 生物
Edwards Lifesciences LLC·IV·Hong Kong MDACS·Registered June 06, 2024
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, USA
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
June 06, 2024
Expiry date
July 16, 2029
Product models
EDWARDS INTUITY Elite System Kits (8300KITB19, 8300KITB21, 8300KITB23, 8300KITB25, 8300KITB27, 8300AB 19mm, 8300AB 21mm, 8300AB 23mm, 8300AB 25mm, 8300AB 27mm, 8300DB19, 8300DB21, 8300DB23, 8300DB25, 8300DB27, 96417)
爱德华兹 INTUITY 精英系统套件 (8300KITB19, 8300KITB21, 8300KITB23, 8300KITB25, 8300KITB27, 8300AB 19mm, 8300AB 21mm, 8300AB 23mm, 8300AB 25mm, 8300AB 27mm, 8300DB19, 8300DB21, 8300DB23, 8300DB25, 8300DB27, 96417)
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