Vietnam MOH registration 2400611ĐKLH/BYT-HTTB

Blood Coagulation Test Machine

VN: Máy xét nghiệm đông máu
Vietnam flagVietnam·Risk Class TTBYT Loại C·CoaguChek® XS System·Roche Diagnostics GmbH·Registered May 10, 2024
Registration details
Analysis ID
2400611ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-211124-0019
Product Type
CoaguChek® XS System
Product Code
04625412019
Company information
Manufacturer Country
GERMANY
Authorized Representative
CÔNG TY TNHH ROCHE VIỆT NAM
Technical details
Intended Use
CoaguChek XS System determines the quantitative prothrombin time (PT/Quick value/INR) using capillary blood from the fingertip or untreated total peripheral blood. It is suitable for self-testing.
Dates and status
Registration Date
May 10, 2024
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About this record

Access comprehensive regulatory information for Blood Coagulation Test Machine 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 2400611ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including Kommanditgesellschaft Behnk Elektronik GmbH & Co., Roche Diagnostics GmbH, 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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