Vietnam MOH registration 2400799ĐKLH/BYT-HTTB

Post-surgery blood drainage system for the autologous blood transfusion system

VN: Bộ dây hút máu dẫn lưu hậu phẫu dùng cho hệ thống truyền máu hoàn hồi

Vietnam·Risk Class TTBYT Loại C·ATP Post OP Set·Fenwal International, Inc.·Registered Jun 20, 2024

Registration details

Analysis ID: 2400799ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230616-0006
Product Type: ATP Post OP Set
Product Code: 9308451

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 or C.A.T.S. blood recovery system. The C.A.T.S. and CATSmart devices, along with the accompanying disposable accessories, are blood recovery systems used to process the blood collected during or after surgery to obtain concentrated red blood cells for transfusion. Additionally, the device is used to prepare the blood before surgery to obtain concentrated red blood cells, plasma, and platelet-rich plasma.

Dates and status

Registration Date: Jun 20, 2024

About this record

Access comprehensive regulatory information for Post-surgery blood drainage system for the autologous blood transfusion system 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 2400799ĐKLH/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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