Hematology Analysis Machine - Vietnam Registration 220003781/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 220003781/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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220003781/PCBB-BYT

Registration Details

Vietnam MOH Registration: 220003781/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

220003781/PCBB-BYT

Submission ID

000.00.04.G18-221230-0032

Product Type

CELL-DYN Emerald (Hematology Analyzer) (name on label: CELL-DYN Emerald)

Technical Details

Intended Use

The Cell-Dyn Emerald is a multi-parameter hematology analyzer intended for use by qualified medical personnel to assess the overall health status in order to support diagnosis and management of diseases related to changes in the blood condition. The Cell-Dyn Emerald classifies and counts the total peripheral blood cells and classifies and counts the red blood cells, white blood cells, and platelets in the blood of individuals who have been treated with the anticoagulant K2EDTA, to provide quantitative results for the following parameters: WBC, LYM%, LYM #, MID%, MID #, GRA%, GRA#, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV