220151
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Edwards Lifesciences LLC·IV·Hong Kong MDACS·Registered August 29, 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 LLCEdwards 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)
- Phone
- 31809428/36192691
Regulatory timeline
- Registration date
- August 29, 2023
- Expiry date
- May 16, 2027
Product models
MITRIS RESILIA Mitral Valve 11400M (11400M25, 11400M27, 11400M29, 11400M31, 11400M33)
米特里斯二尖瓣 11400M (11400M25, 11400M27, 11400M29, 11400M31, 11400M33)
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