Automatic Blood Coagulation Analyzer
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·Registered Oct 22, 2024- Analysis ID
- 2402913ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240427-0001
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM
- 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.
- Registration Date
- Oct 22, 2024
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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.
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