Vietnam MOH registration 2403300ĐKLH/BYT-HTTB

Automated Blood Component Separation Machine's White Blood Cell Collector

VN: Bộ thu nhận bạch cầu dùng cho máy chiết tách thành phần máu tự động

Vietnam·Risk Class TTBYT Loại C·C4Y White Blood Cell Set·Fresenius HemoCare Netherlands B.V.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403300ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211127-0008
Product Type: C4Y White Blood Cell Set
Product Code: 9400301

Company information

Manufacturer: Fresenius HemoCare Netherlands B.V.
Manufacturer Country: NETHERLANDS
Product Owner: Fresenius Medical Care
Authorized Representative: CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM

Technical details

Intended Use: The kit is used in combination with the COM.TEC automated blood component separation machine to separate mononuclear cells (peripheral blood stem cells and/or lymphocytes) by the double-knife technique. The single-knife mode can be used in emergencies.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Automated Blood Component Separation Machine's White Blood Cell Collector in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403300ĐKLH/BYT-HTTB and manufactured by Fresenius HemoCare Netherlands B.V.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM.

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