Automatic Biochemical Analyzer - Vietnam Registration 2200281ĐKLH/BYT-TB-CT

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 2200281ĐKLH/BYT-TB-CT and manufactured by Beckman Coulter Mishima K.K..

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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2200281ĐKLH/BYT-TB-CT

Registration Details

Vietnam MOH Registration: 2200281ĐKLH/BYT-TB-CT

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Device Details

Automatic Biochemical Analyzer

VN: Máy xét nghiệm sinh hóa tự động

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2200281ĐKLH/BYT-TB-CT

Submission ID

19010387/ĐKLH-BYT-TB-CT

Product Type

Beckman Coulter Chemistry analyzer AU480

Technical Details

Intended Use

The measurement of the analytes in the sample combined with the reagent, the reference standard, the quality control (QC) material and any other appropriate accessories. This system is intended for in vitro diagnostic use only. The product measures the chemical components in the sample (serum, plasma, urine and whole blood (only HbA1c)) by mixing (turbidimetry) the sample and the reagent. Please refer to the reagent instructions for details on the measurement requirements.