hCG Qualitative Test Kit - Vietnam Registration 240000754/PCBB-HCM

Access comprehensive regulatory information for hCG Qualitative 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 240000754/PCBB-HCM and manufactured by Diagnosis F Biotech Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH SẢN XUẤT CÔNG NGHỆ SINH HỌC DIAGNOSIS F.

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including GeneSign Biotech (Xiamen) Co., Ltd, Acro Biotech Inc., and 4 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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240000754/PCBB-HCM

Registration Details

Vietnam MOH Registration: 240000754/PCBB-HCM

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Device Details

hCG Qualitative Test Kit

VN: Que thử xét nghiệm định tính chỉ số hCG

Risk Class TTBYT Loại B

Registration Details

Analysis ID

240000754/PCBB-HCM

Submission ID

000.00.19.H29-240404-0022

Product Type

dfu EASY TEST ONE MOMENT Strip

Product Code

H36

Technical Details

Intended Use

Human chorionic gonadotropin (hCG) is a hormone secreted by the placenta from the very early stages of pregnancy, hence hCG is an indicator that helps in early diagnosis of pregnancy. dfu EASY TEST ONE MOMENT Strip can diagnose pregnancy by detecting the presence of hCG in urine at concentrations as low as 10 mIU/mL.