IVD Hemolysis - Vietnam Registration 240001249/PCBA-HCM

Access comprehensive regulatory information for IVD Hemolysis in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240001249/PCBA-HCM and manufactured by Meril Diagnostics Pvt. Ltd. The authorized representative in Vietnam is CÔNG TY TNHH MERIL (VIỆT NAM).

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including Meril Diagnostics Pvt. Ltd, Tecom Science Corporation, 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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240001249/PCBA-HCM

Registration Details

Vietnam MOH Registration: 240001249/PCBA-HCM

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Device Details

IVD Hemolysis

VN: IVD ly giải hồng cầu

Risk Class TTBYT Loại A

Registration Details

Analysis ID

240001249/PCBA-HCM

Submission ID

000.00.19.H29-240312-0018

Product Type

Lyse AriQuant- SYS

Technical Details

Intended Use

The test reagent is used on the CelQuant 3 Prime (3PDA) hematology analyzer and the Sysmex (3PDA) hematology analyzer, for the quantification of the number of white blood cells, lymphocytes, mid-size cells, granulocytes, and the analysis of the distribution of the three-peak sizes of WBC, and the measurement of hemoglobin concentration.