Automatic Biochemical Analyzer - Vietnam Registration 2403193ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Automatic Biochemical 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 2403193ĐKLH/BYT-HTTB and manufactured by Beckman Coulter Mishima K.K.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including LINEAR CHEMICALS, S.L.U, Dirui Industrial 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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2403193ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403193ĐKLH/BYT-HTTB

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Device Details

Automatic Biochemical Analyzer

VN: Máy xét nghiệm hóa sinh tự động

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2403193ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-240723-0008

Product Type

AU5800

Product Code

B96697

Technical Details

Intended Use

The AU5800 biochemical analyzer measures various analytes in samples, combined with reagents, reference materials (QC), and appropriate accessories. It is intended for in vitro diagnostic use only. It is a device for measuring the concentrations of various biochemical components in samples (serum, plasma, urine, whole blood (only for HbA1c testing)) by mixing (homogenizing) the sample and the reagent.