IVD Department Quantitative HbA1c Testing - Vietnam Registration 240001260/PCBB-HN

Access comprehensive regulatory information for IVD Department Quantitative HbA1c Testing 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 240001260/PCBB-HN and manufactured by Wuxi Biohermes Bio & Medical Technology Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH STV TECHNOLOGY.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Theo theo phụ lục, Theo phụ lục, 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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240001260/PCBB-HN

Registration Details

Vietnam MOH Registration: 240001260/PCBB-HN

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Device Details

IVD Department Quantitative HbA1c Testing

VN: Bộ IVD xét nghiệm định lượng HbA1c

Risk Class TTBYT Loại B

Registration Details

Analysis ID

240001260/PCBB-HN

Submission ID

000.00.19.H26-240523-0027

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography) is used in conjunction with the A1cChek Pro HbA1c analyzer to measure the quantitative level of HbA1c in the whole blood. Glycohemoglobin Quality Control is used as a quality control material to monitor the accuracy of the HbA1c testing process and the quantitative HbA1c test kit by the boronate affinity chromatography method.