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Prothrombin Time Quantitative Test - Vietnam Registration 2403377ĐKLH/BYT-HTTB

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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2403377ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403377ĐKLH/BYT-HTTB
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Device Details

Prothrombin Time Quantitative Test
VN: Que thử xét nghiệm định lượng thời gian prothrombin
Risk Class TTBYT Loại C

Registration Details

2403377ĐKLH/BYT-HTTB

17004153/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Technical Details

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

Nov 06, 2024

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