Vietnam MOH registration 240000034/PCBB-NA

Qualitative hCG Index Test (Pregnancy Test)

VN: Que thử xét nghiệm định tính chỉ số hCG (Que thử thai)

Vietnam·Risk Class TBYT Loại B·Nintest·Diagnosis F Biotech Co., Ltd·Registered Sep 21, 2024

Registration details

Analysis ID: 240000034/PCBB-NA
Submission ID: 000.00.48.H41-240920-0001
Product Type: Nintest

Company information

Manufacturer: Diagnosis F Biotech Co., Ltd
Product Owner: CÔNG TY TNHH NINMED
Authorized Representative: CÔNG TY TNHH NINMED

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. Nintest can diagnose pregnancy through the presence of hCG in urine at concentrations as low as 10 mIU/mL.

Dates and status

Registration Date: Sep 21, 2024

About this record

Access comprehensive regulatory information for Qualitative hCG Index Test (Pregnancy Test) 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 240000034/PCBB-NA and manufactured by Diagnosis F Biotech Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH NINMED.

This page provides complete technical specifications, regulatory compliance details. 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.