Artificial Heart - Vietnam Registration 2403516ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Artificial Heart in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403516ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH MERIL (VIỆT NAM).
This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Medtronic Heart Valves Division; Medtronic Mexico S. de R.L de CV, Contract Sterilization Services Pte Ltd., and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2403516ĐKLH/BYT-HTTB
000.00.04.G18-231211-0020
Theo theo phụ lục
Theo phụ lục
Technical Details
The Dafodil aortic valve, a biocompatible membrane-based valve, is indicated for patients with severe aortic valve disease, where the native valve is no longer functional and requires replacement. The device is also designed for patients who have a prosthetic aortic valve and a native mitral valve that is no longer functioning properly and requires replacement. In the latter case, the previous prosthetic valve will be surgically removed and replaced with the new prosthetic valve.
Dates and Status
Nov 14, 2024
Medtronic Heart Valves Division; Medtronic Mexico S. de R.L de CV
Contract Sterilization Services Pte Ltd.
Contract Sterilization Services Pte Ltd.
Edwards Lifesciences LLC; Edwards Lifesciences (Singapore) Pte Ltd
Medtronic Heart Valves Division; Medtronic Mexico S. de R.L de CV; Medtronic Inc.
Artificial Heart Valve
Theo theo phụ lục
2301535ĐKLH/BYT-HTTB
Blood wiring kit of an artificial heart-lung machine
Terumo Custom Tubing Pack Dùng cho Bệnh nhân dưới 10kg
Contract Sterilization Services Pte Ltd.
472528
Blood wiring kit of an artificial heart-lung machine
Terumo Custom Tubing PackBộ dây truyền GĐ; >40 kg
Contract Sterilization Services Pte Ltd.
443760
Blood wiring kit of an artificial heart-lung machine
Terumo Custom Tubing Pack Bộ dây truyền cho bệnh nhân 10-15 kg
Contract Sterilization Services Pte Ltd.
443742
Blood wiring kit of an artificial heart-lung machine
Terumo Custom Tubing Pack Bộ dây truyền cho bệnh nhân < 10kg
Contract Sterilization Services Pte Ltd.
443750