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.
Device Details
Registration Details
240000066/PCBB-BN
000.00.16.H05-240911-0003
MEK-9200
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
Automated Hematology Analyzer
TECOM SCIENCE CORPORATION
240002909/PCBB-HN
Automated Hematology Analyzer and Chemicals for the Machine
Genrui Biotech Inc
240002736/PCBB-HN
Automated Hematology Analyzer and Chemicals for the Machine
Shenzhen Dymind Biotechnology Co., Ltd
240002737/PCBB-HN
Automated Hematology Analyzer
Nihon Kohden
240000064/PCBB-BN
Automated Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
240000013/PCBB-VP

