Automatic Blood Coagulation Analyzer - Vietnam Registration 2403576ĐKLH/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 2403576ĐKLH/BYT-HTTB and manufactured by Sysmex Corporation. The authorized representative in Vietnam is CÔNG TY TNHH SYSMEX 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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2403576ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403576ĐKLH/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

2403576ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-210202-0011

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

The Sysmex CS-2400/CS-2500 is a fully automated blood coagulation test device designed for in-vitro diagnostic use to assess blood clotting parameters by point-of-care, colorimetric, immunoassay and precipitation methods. The primary sample for analysis is the blood plasma with an added blood clotting inhibitor (sodium citrate). However, if a sample for analysis is designated to contain a test drug, follow the instructions for that drug. This device is not intended for any other purpose. Only the reagents and cleaning solutions specified in this manual are permitted for use. The conditions of use also apply to compliance with the cleaning and maintenance procedures described in this manual.