Automatic Biochemical Analyzer - Vietnam Registration 2403392ĐKLH/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 2403392ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics International Ltd. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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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2403392ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403392ĐKLH/BYT-HTTB

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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

2403392ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-231130-0005

Product Type

cobas c 111 analyzer

Product Code

04528778001

Technical Details

Intended Use

cobas c 111 is a continuous random access analyzer used to determine in vitro clinical chemical parameters in serum, plasma, urine, or whole blood (HbA1c). cobas c 111 is intended for professional laboratory use. cobas c 111 is not intended for patient-side testing. The analyzer is optimized for a maximum throughput of 50 samples per day, using spectroscopic analysis. The operator must read this manual carefully before operating the system.