Automatic Biochemical Analyzer - Vietnam Registration 2403575ĐKLH/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 2403575ĐKLH/BYT-HTTB and manufactured by Thermo Fisher Scientific Oy. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC 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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2403575ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403575ĐKLH/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

2403575ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-231129-0001

Product Type

INDIKO

Product Code

98630000

Technical Details

Intended Use

Thermo Scientific Indiko Clinical Biochemistry Workstations are fully automated random access workstations for routine and special biochemical assays, including specific proteins, therapeutic drugs, and drugs of abuse. Indiko Clinical Biochemistry Workstations are intended to be used in the diagnosis of disease or other conditions, including the determination of health status, for the purpose of treatment, mitigation, therapy, or prevention of disease. Indiko and all reagents in this system are intended only for research diagnostic use in the laboratory. The device is intended to be used by trained personnel who have basic knowledge of the operation of the workstations.