Coagulation Analysis Machine - Vietnam Registration 240001404/PCBB-HCM

Access comprehensive regulatory information for Coagulation Analysis Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001404/PCBB-HCM and manufactured by SysCan MedTech (Suzhou) Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT Y TẾ VINH HIỂN ĐẠT.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, Biobase Biodustry (Shandong) Co.,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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240001404/PCBB-HCM

Registration Details

Vietnam MOH Registration: 240001404/PCBB-HCM

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Device Details

Coagulation Analysis Machine

VN: Máy phân tích đông máu

Risk Class TTBYT Loại B

Registration Details

Analysis ID

240001404/PCBB-HCM

Submission ID

000.00.19.H29-240426-0009

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

The automated hemostasis analyzer is designed strictly for professional clinical laboratory diagnosis. It is an automated tool. This analyzer uses three methods: the coagulation method, the turbidimetric immunoassay method, and the chromogenic substrate method, to be used clinically in the qualitative or quantitative detection of the coagulation and anticoagulation, fibrinolysis and antifibrinolysis functions of the analytes in the human blood serum samples.