Hematology Analysis Machine - Vietnam Registration 220003785/PCBB-BYT

Access comprehensive regulatory information for Hematology Analysis 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 220003785/PCBB-BYT and manufactured by BIT Analytical Instruments GmbH.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, DIATRON MI Zrt, 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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220003785/PCBB-BYT

Registration Details

Vietnam MOH Registration: 220003785/PCBB-BYT

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Device Details

Hematology Analysis Machine

VN: Máy phân tích huyết học

Risk Class TTBYT Loại B

Registration Details

Analysis ID

220003785/PCBB-BYT

Submission ID

000.00.04.G18-221230-0040

Product Type

CELL-DYN Emerald 22 AL Instrument (as per the label: CELL-DYN Emerald 22 AL)

Technical Details

Intended Use

The CELL-DYN Emerald 22 AL Hematology Analyzer is an automated, multi-parameter blood analysis instrument used in in-vitro diagnostic testing. It is utilized by medical specialists to assess general health, aiding in the diagnosis and management of conditions related to changes in blood status. The CELL-DYN Emerald 22 AL differentiates and counts the cells in the whole blood of veins and capillaries, which have been anticoagulated with K2EDTA, to provide quantitative results for the following indices: WBC, LYM%, LYM #, MON%, MON #, NEU%, NEU #, EOS%, EOS #, BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV.