Vietnam MOH registration 2402841ĐKLH/BYT-HTTB

Photopheresis with UV radiation

VN: Kít chiếu tia UV túi tiểu cầu

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Oct 22, 2024

Registration details

Analysis ID: 2402841ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231130-0018
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM

Technical details

Intended Use: It is used in conjunction with the Mirasol blood bag irradiation device for the UV irradiation process of the blood bag to reduce the amount of residual non-viable white blood cells in the donated platelets intended for transfusion. The Mirasol system can be used instead of gamma irradiation to prevent graft-versus-host disease (GVHD) associated with blood transfusion (TA-GVHD). The Mirasol system combined with leukocyte filtration can be used as an alternative to CMV virus testing to prevent CMV infection during blood transfusion

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Photopheresis with UV radiation 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 2402841ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM.

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