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Automated Hematology Analyzer - Vietnam Registration 240000066/PCBB-BN

Access comprehensive regulatory information for Automated Hematology Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240000066/PCBB-BN and manufactured by Nihon Kohden. The authorized representative in Vietnam is CHI NHÁNH CÔNG TY CỔ PHẦN SẢN XUẤT VÀ DỊCH VỤ TRÀNG AN TẠI BẮC NINH.

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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240000066/PCBB-BN
Registration Details
Vietnam MOH Registration: 240000066/PCBB-BN
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Device Details

Automated Hematology Analyzer
VN: Máy phân tích huyết học tự động
Risk Class TBYT Loại B

Registration Details

240000066/PCBB-BN

000.00.16.H05-240911-0003

MEK-9200

Company Information

Theo theo phụ lục

Nihon Kohden

Technical Details

It is intended for in vitro diagnostic use only. The MEK-9200 Hematology Analyzer is designed for in vitro diagnostic use to automatically classify and quantify the following parameters (full blood count, CBC, and the 5 differential components of neutrophils and erythrocytes) in EDTA-anticoagulated whole blood: White blood cells (WBC), number and percentage of neutrophils (NE and NE%), number and percentage of lymphocytes (LY and LY%), number and percentage of monocytes (MO and MO%), number and percentage of eosinophils (EO and EO%), number and percentage of basophils (BA and BA%), Red blood cells (RBC), Hemoglobin concentration (HGB), Hematocrit percentage (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width based on coefficient of variation (RDW-CV), Red cell distribution width based on standard deviation (RDW-SD), Platelets (PLT), Platelet distribution ratio (PCT), Mean platelet volume (MPV), Platelet width (PDW), Ratio of large platelets (P-LCR), Number of large platelets (P-LCC), Percentage of reticulocytes (RET), Number of reticulocytes (RET), Ratio of immature reticulocytes (IRF), Low fluorescence ratio (LFR), Mean fluorescence ratio (MFR) and High fluorescence ratio (HFR). The measurement of CBC, WBC and reticulocytes can support the diagnosis of anemia, inflammation and infection. The test population group is a general group of patients being evaluated for various conditions. The MEK-9200 Hematology Analyzer is intended for professional use in the laboratory.

Dates and Status

Sep 30, 2024