Automated Hematology Analyzer - Vietnam Registration 240000064/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 240000064/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.

Free Database

300,000+ Devices

5 Competitors

5 Recent Registrations

240000064/PCBB-BN

Registration Details

Vietnam MOH Registration: 240000064/PCBB-BN

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

Automated Hematology Analyzer

VN: Máy phân tích huyết học tự động

Risk Class TBYT Loại B

Registration Details

Analysis ID

240000064/PCBB-BN

Submission ID

000.00.16.H05-240910-0002

Product Type

MEK-1301

Technical Details

Intended Use

For in vitro diagnostic use only. The MEK-1301 automated hematology analyzer is designed for in vitro diagnostic use to automatically classify and quantify the following parameters (full blood count, CBC) in the whole blood of EDTA-processed individuals: White blood cells (WBC), number and percentage of lymphocytes (LY and LY%), number and percentage of monocytes (MO and MO%), number and percentage of granulocytes (GR and GR%), number of red blood cells (RBC), concentration of hemoglobin (HGB), percentage (HCT), mean corpuscular volume (MCV), mean hemoglobin concentration (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets (PLT), coefficient of variation of red blood cell distribution width (RDW-CV), standard deviation of red blood cell distribution width (RDW-SD), plateletcrit (PCT), mean platelet volume (MPV), platelet distribution width (PDW), and large platelet ratio (PLCR). The full blood count (CBC) can support the diagnosis of anemia, inflammation, and infection. The test sample is the general population, and the CBC test is used to evaluate various conditions. The MEK-1301 automated hematology analyzer is intended for use in the laboratory setting only.