Vietnam MOH registration 2403377ĐKLH/BYT-HTTB

Prothrombin Time Quantitative Test

VN: Que thử xét nghiệm định lượng thời gian prothrombin
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 06, 2024
Registration details
Analysis ID
2403377ĐKLH/BYT-HTTB
Submission ID
17004153/ĐKLH-BYT-TB-CT
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Authorized Representative
CÔNG TY TNHH ROCHE VIỆT NAM
Technical details
Intended Use
CoaguChek XSPT Test PST is an in-vitro test used to determine prothrombin time (PT) for monitoring therapy with vitamin K antagonists using the CoaguChek INRange/CoaguChek XS. The test uses fresh peripheral blood and is intended for self-testing by patients.
Dates and status
Registration Date
Nov 06, 2024
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About this record

Access comprehensive regulatory information for Prothrombin Time Quantitative Test in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403377ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Theo phụ lục, and 1 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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