Vietnam MOH registration 240000067/PCBB-BN

Hematology analyzer and automated blood sedimentation rate measurement

VN: Máy phân tích huyết học và đo tốc độ máu lắng tự động

Vietnam·Risk Class TBYT Loại B·MEK-1305·Nihon Kohden·Registered Sep 30, 2024

Registration details

Analysis ID: 240000067/PCBB-BN
Submission ID: 000.00.16.H05-240911-0002
Product Type: MEK-1305

Company information

Manufacturer: Nihon Kohden
Manufacturer Country: Theo theo phụ lục
Product Owner: Nihon Kohden
Authorized Representative: CHI NHÁNH CÔNG TY CỔ PHẦN SẢN XUẤT VÀ DỊCH VỤ TRÀNG AN TẠI BẮC NINH

Technical details

Intended Use: For in vitro diagnostic use only. The MEK-1305 hematology analyzer and the automated measurement of the erythrocyte sedimentation rate (ESR) is designed for in vitro diagnostic use to automatically classify and quantify the following parameters (full blood count, CBC and ESR) in EDTA-anticoagulated whole blood from patients as a diagnostic aid in clinical laboratories:White blood cell count (WBC), Lymphocyte count and percentage (LY and LY%), Monocyte count and percentage (MO and MO%), Eosinophil count and percentage (GR and GR%), Red blood cell count (RBC), Hemoglobin concentration (HGB), Hematocrit percentage (HCT), Mean corpuscular volume (MCV), Mean hemoglobin concentration (MCH), Mean hemoglobin concentration per red blood cell (MCHC), Platelet count (PLT), Coefficient of variation of the red blood cell size distribution (RDW-CV), Standard deviation of the red blood cell size distribution (RDW-SD), Plateletcrit (PCT), Mean platelet volume (MPV), Platelet size distribution (PDW), Proportion of large platelets (P-LCR), and Erythrocyte sedimentation rate (ESR). The measurement of CBC and ESR can support the diagnosis of anemia, inflammation, and infection. The target population for testing is the general population being evaluated for various conditions. The MEK-1305 hematology analyzer and the automated measurement of the erythrocyte sedimentation rate (ESR) is intended for use by laboratory personnel only.

Dates and status

Registration Date: Sep 30, 2024

About this record

Access comprehensive regulatory information for Hematology analyzer and automated blood sedimentation rate measurement 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 240000067/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. 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.