180111
Prostheses, Cardiac Valve, Biological
假体, 心脏瓣膜, 生物
Edwards Lifesciences LLC·IV·Hong Kong MDACS·Registered March 03, 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, United States Of America爱德华兹路一号, 尔湾 CA 92614, 美国
Authorised representative (AR)
- Phone
- 31809428/36192691
Regulatory timeline
- Registration date
- March 03, 2023
- Expiry date
- May 04, 2028
Product models
Carpentier Edwards Perimount RSR Pericardial Bioprosthesis (2800TFX19MM, 2800TFX21MM, 2800TFX23MM, 2800TFX25MM, 2800TFX27MM, 2800TFX29MM), Carpentier Edwards Perimount Magna Ease Pericardial Bioprosthesis (3300TFX19MM, 3300TFX21MM, 3300TFX23MM, 3300TFX25MM, 3300TFX27MM, 3300TFX29MM), Carpentier Edwards Perimount Plus Pericardial Bioprosthesis (6900PTFX25, 6900PTFX27, 6900PTFX29, 6900PTFX31, 6900PTFX33), Carpentier Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis (7300TFX25, 7300TFX27, 7300TFX29, 7300TFX31, 7300TFX33)
卡彭蒂埃爱德华兹 Perimount RSR 心包生物假体 (2800TFX19MM, 2800TFX21MM, 2800TFX23MM, 2800TFX25MM, 2800TFX27MM, 2800TFX29MM), 卡彭蒂埃爱德华兹 Perimount Magna Ease 心包生物假体 (3300TFX19MM, 3300TFX21MM, 3300TFX23MM, 3300TFX23MM, 3 300TFX25MM, 3300TFX27MM, 3300TFX29MM), 卡彭蒂埃爱德华兹周边加心包生物假体 (6900PTFX25, 6900PTFX27, 6900PTFX29, 6900PTFX31, 6900PTFX33), 卡彭蒂埃爱德华兹周大尖瓣二尖瓣缓解心包生物假体 (7300TFX25, 7300TFX27、7300TFX29、7300TFX31、7300TFX33)
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