Vietnam MOH registration 2200281ĐKLH/BYT-TB-CT

Automatic Biochemical Analyzer

VN: Máy xét nghiệm sinh hóa tự động
Vietnam flagVietnam·Risk Class TTBYT Loại C·Beckman Coulter Chemistry analyzer AU480·Beckman Coulter Mishima K.K.·Registered Dec 29, 2022
Registration details
Analysis ID
2200281ĐKLH/BYT-TB-CT
Submission ID
19010387/ĐKLH-BYT-TB-CT
Product Type
Beckman Coulter Chemistry analyzer AU480
Company information
Manufacturer Country
JAPAN
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.
Dates and status
Registration Date
Dec 29, 2022
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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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