Automatic Blood Coagulation Analyzer - Vietnam Registration 2402913ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Automatic Blood Coagulation Analyzer 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 2402913ĐKLH/BYT-HTTB and manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, SYSMEX CORPORATION i-Square, 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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2402913ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2402913ĐKLH/BYT-HTTB

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Device Details

Automatic Blood Coagulation Analyzer

VN: Máy xét nghiệm đông máu tự động

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2402913ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-240427-0001

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

The device is an automated quantitative blood coagulation analyzer used for in vitro diagnosis in clinical laboratories; it helps perform blood coagulation and anticoagulation tests, as well as fibrinolysis and anti-fibrinolysis tests on blood plasma samples. The device analyzes hemostasis and coagulation parameters by the coagulation method, the chromogenic substrate method, and the turbidimetric immunodetection method.