HbA1c and ACR Testing Machine - Vietnam Registration 240001652/PCBB-HN
Access comprehensive regulatory information for HbA1c and ACR Testing Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loแบกi B medical device is registered under number 240001652/PCBB-HN and manufactured by i-SENS Songdo Factory 2. The authorized representative in Vietnam is CรNG TY TNHH VIแปT PHAN.
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Device Details
Registration Details
240001652/PCBB-HN
000.00.19.H26-240703-0018
A1Care Analyzer
Technical Details
A1Care Analyzer is an in vitro diagnostic (IVD) device used in point-of-care (POC) testing to measure HbA1c (% and mmol/mol) in whole blood samples (venous and arterial) or albumin, creatinine, and albumin/creatinine (ACR) in urine samples. A1Care Analyzer is used by medical professionals in the lab, such as clinics and hospitals, for patients with diabetes or kidney disease.
Dates and Status
Jul 10, 2024