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Quantitative galactose test (galactose and galactose-1-phosphate) - Vietnam Registration 240001390/PCBB-HCM

Access comprehensive regulatory information for Quantitative galactose test (galactose and galactose-1-phosphate) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001390/PCBB-HCM and manufactured by Zentech SA. The authorized representative in Vietnam is CÔNG TY TNHH GAM MA VIỆT BỈ.

This page provides complete technical specifications, regulatory compliance details. 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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240001390/PCBB-HCM
Registration Details
Vietnam MOH Registration: 240001390/PCBB-HCM
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Device Details

Quantitative galactose test (galactose and galactose-1-phosphate)
VN: Bộ xét nghiệm định lượng galactose toàn phần (galactose và galactose-1-phosphate)
Neonatal Total Galactose Screening Assay
Risk Class TTBYT Loại B

Registration Details

240001390/PCBB-HCM

000.00.19.H29-240605-0008

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Zentech SA

Technical Details

Screening for galactosemia in newborns using dried blood spots on filter paper 903 or 226. The medical professionals use the test kit to screen for galactosemia. The test is performed on an automated or semi-automated system.

Dates and Status

Jul 08, 2024