Vietnam MOH registration 2400929ĐKLH/BYT-HTTB

Kit for the isolation of blood cells and stem cells

VN: Bộ kit tách bạch cầu và tế bào gốc

Vietnam·Risk Class TTBYT Loại C·P1YA White Blood Cell Set·Fenwal International, Inc·Registered Jul 21, 2024

Registration details

Analysis ID: 2400929ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231103-0042
Product Type: P1YA White Blood Cell Set
Product Code: 9400431

Company information

Manufacturer: Fenwal International, Inc
Manufacturer Country: DOMINICAN REPUBLIC
Product Owner: Fresenius Medical Care
Authorized Representative: CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM

Technical details

Intended Use: The combination of the manual cell collection kit and the COM.TEC automated blood component separation machine enables the collection of mononuclear cells and peripheral blood stem cells using the double-knife technique.

Dates and status

Registration Date: Jul 21, 2024

About this record

Access comprehensive regulatory information for Kit for the isolation of blood cells and stem cells 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 2400929ĐKLH/BYT-HTTB and manufactured by Fenwal International, Inc. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM.

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