Vietnam MOH registration 240001392/PCBB-HCM

Phenylalanine Quantitative Test Kit

VN: Bộ xét nghiệm định lượng phenylalanine
Neonatal PKU Screening Assay
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Zentech SA·Registered Jul 08, 2024
Registration details
Analysis ID
240001392/PCBB-HCM
Submission ID
000.00.19.H29-240613-0021
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
The quantitative determination of phenylalanine (Phe) in dried blood spots from newborns on filter paper 903 or 226. Medical professionals use the test to screen for phenylketonuria (Phenylketo niệu). The test is performed on a semi-automatic or automatic system.
Dates and status
Registration Date
Jul 08, 2024
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About this record

Access comprehensive regulatory information for Phenylalanine Quantitative Test Kit 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 240001392/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, 2 companies making similar products including Wallac OY, Calbiotech Inc., 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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