Vietnam MOH registration 2400409ĐKLH/BYT-HTTB

Plasma Separator for Reinfusion Hemodilution Machine

VN: Bộ tách huyết tương dùng cho máy truyền máu hoàn hồi

Vietnam·Risk Class TTBYT Loại C·PSQ Set·Fenwal International, Inc.·Registered Mar 02, 2024

Registration details

Analysis ID: 2400409ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211120-0004
Product Type: PSQ Set
Product Code: 9005141

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 device is designed to be used with the CATSmart blood salvage system. It is used in the program of blood fractionation from the units of blood collected before, during and after surgery, to form concentrated red blood cells (PRC), plasma (PLS) and platelet-rich plasma (PRP).

Dates and status

Registration Date: Mar 02, 2024

About this record

Access comprehensive regulatory information for Plasma Separator for Reinfusion Hemodilution Machine 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 2400409ĐKLH/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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