Vietnam MOH registration 2403516ĐKLH/BYT-HTTB

Artificial Heart

VN: Van tim nhân tạo
Vietnam flagVietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Nov 14, 2024
Registration details
Analysis ID
2403516ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-231211-0020
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Authorized Representative
CÔNG TY TNHH MERIL (VIỆT NAM)
Technical details
Intended Use
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
Registration Date
Nov 14, 2024
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About this record

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.

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