Vietnam MOH registration 240001781/PCBA-HCM

IVD Quantitative Hematology Testing System

VN: Hệ thống IVD xét nghiệm định lượng huyết học

Vietnam·Risk Class TBYT Loại A·Theo theo phụ lục·Hunan Ehome Health Technology Company Limited·Registered Nov 18, 2024

Registration details

Analysis ID: 240001781/PCBA-HCM
Submission ID: 000.00.19.H29-241030-0015
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Hunan Ehome Health Technology Company Limited
Manufacturer Country: Theo theo phụ lục
Product Owner: Hunan Ehome Health Technology Company Limited
Authorized Representative: CÔNG TY CỔ PHẦN CÔNG NGHỆ MEDIEXPRESS VIỆT NAM

Technical details

Intended Use: The hematology analyzer is used in the full blood count and white blood cell count of human blood. The sample processing unit includes a four-well sampler, a cell lysis solution for blood cell analysis, a dilution solution for blood cell analysis, and a cell counting chamber. The four-well sampler is used to collect and store human blood. The cell lysis solution for blood cell analysis is used to break down red blood cells, dissolve hemoglobin, and maintain the shape of the cells for analysis prior to blood cell analysis, to facilitate the counting of differential cells or the determination of hemoglobin concentration. The dilution solution for blood cell analysis is used to dilute the sample before blood cell analysis and to prepare the blood cell suspension. The blood cell counting chamber is used to count the formed elements in blood samples and body fluids in clinical settings

Dates and status

Registration Date: Nov 18, 2024

About this record

Access comprehensive regulatory information for IVD Quantitative Hematology Testing System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240001781/PCBA-HCM and manufactured by Hunan Ehome Health Technology Company Limited. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN CÔNG NGHỆ MEDIEXPRESS VIỆT NAM.

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