Automated Hematology Analyzer - Vietnam Registration 230000017/PCBB-BD

Access comprehensive regulatory information for Automated Hematology Analyzer 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 230000017/PCBB-BD and manufactured by Horiba ABX SAS.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, Horiba ABX SAS, 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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230000017/PCBB-BD

Registration Details

Vietnam MOH Registration: 230000017/PCBB-BD

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Device Details

Automated Hematology Analyzer

VN: Máy xét nghiệm huyết học tự động

Risk Class TTBYT Loại B

Registration Details

Analysis ID

230000017/PCBB-BD

Submission ID

000.00.17.H09-230414-0007

Product Type

Yumizen H500 CT

Technical Details

Intended Use

Yumizen H500 CT classifies and lists the following parameters in the whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, MIC, MAC, PLT, MPV, PCT, PDW, P-LCC, P-LCR, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS%, ALY#, ALY%, LIC#, LIC%, IML#, IML%, IMM#, IMM%, IMG#, IMG%. Yumizen H500 CT provides information for in vitro diagnostic use in clinical laboratories. It is used to screen the physiological state (detection of quantitative or qualitative abnormalities in hematology) or the pathological state of the population of patients found in clinical laboratories. It is quantitative to measure the parameters and qualitative to detect the warnings. The purpose of Yumizen H500 CT is to determine blood samples from humans as: -venous blood -capillary blood obtained in blood anticoagulated with K2-EDTA and K3-EDTA. The purpose of Yumizen H500 CT is to determine blood samples from humans as: - pediatrics (newborns, children, infants, adolescents) - adult population