Vietnam MOH registration 240001390/PCBB-HCM

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

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Zentech SA·Registered Jul 08, 2024

Registration details

Analysis ID: 240001390/PCBB-HCM
Submission ID: 000.00.19.H29-240605-0008
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Zentech SA
Manufacturer Country: Theo theo phụ lục
Product Owner: Zentech SA
Authorized Representative: CÔNG TY TNHH GAM MA VIỆT BỈ

Technical details

Intended Use: 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

Registration Date: Jul 08, 2024

About this record

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.

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