IVD Department Quantitative HbA1c Testing - Vietnam Registration 240002229/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 TBYT Loại B medical device is registered under number 240002229/PCBB-HN and manufactured by I.S.E. S.r.l. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI KỸ THUẬT TPCOM.

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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240002229/PCBB-HN

Registration Details

Vietnam MOH Registration: 240002229/PCBB-HN

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Device Details

IVD Department Quantitative HbA1c Testing

VN: Bộ IVD xét nghiệm định lượng HbA1c

Risk Class TBYT Loại B

Registration Details

Analysis ID

240002229/PCBB-HN

Submission ID

000.00.19.H26-240827-0010

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

-HbA1c: to determine the in vitro concentration of Hemoglobin A1c (HbA1c) in human serum or plasma. -HbA1c Calibrator: used to calibrate the quantitative test for Hemoglobin A1c (HbA1c) in human serum or plasma. -HbA1c Control High/ HbA1c Control low: used to control the quality of the quantitative test for Hemoglobin A1c (HbA1c) in human serum or plasma.