Vietnam MOH registration 240001652/PCBB-HN

HbA1c and ACR Testing Machine

VN: Máy xét nghiệm HbA1c và ACR

Vietnam·Risk Class TTBYT Loại B·A1Care Analyzer·i-SENS Songdo Factory 2·Registered Jul 10, 2024

Registration details

Analysis ID: 240001652/PCBB-HN
Submission ID: 000.00.19.H26-240703-0018
Product Type: A1Care Analyzer

Company information

Manufacturer: i-SENS Songdo Factory 2
Product Owner: i-SENS, Inc
Authorized Representative: CÔNG TY TNHH VIỆT PHAN

Technical details

Intended Use: 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

Registration Date: Jul 10, 2024

About this record

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 Loại B medical device is registered under number 240001652/PCBB-HN and manufactured by i-SENS Songdo Factory 2. The authorized representative in Vietnam is CÔNG TY TNHH VIỆT PHAN.

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