Vietnam MOH registration 2402787ĐKLH/BYT-HTTB

Platelet Concentration Kit

VN: Bộ dụng cụ gom tiểu cầu

Vietnam·Risk Class TTBYT Loại C·Disposable plastic blood bag with leukocyte-reduced filter (as labeled: Pooling bag 500ml)·Jiaxing Tianhe Pharmaceutical Co., Ltd·Registered Oct 02, 2024

Registration details

Analysis ID: 2402787ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230728-0005
Product Type: Disposable plastic blood bag with leukocyte-reduced filter (as labeled: Pooling bag 500ml)
Product Code: TrP1500-PF-H7SW

Company information

Manufacturer: Jiaxing Tianhe Pharmaceutical Co., Ltd
Manufacturer Country: CHINA
Product Owner: Jiaxing Tianhe Pharmaceutical Co., Ltd
Authorized Representative: CÔNG TY CỔ PHẦN MEDCOMTECH

Technical details

Intended Use: Used for the filtration of the granulocytes from a concentrate containing up to 10 units of concentrated granulocytes or from a unit of granulocytes from a blood donor through a blood component separation machine (apheresis). The product has been sterilized by Ethylene Oxide. Sterilized in a sealed, odorless, transparent plastic bag and does not contain any fever-producing substances. Final product: concentrated granulocyte concentrate free of granulocytes.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for Platelet Concentration Kit 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 2402787ĐKLH/BYT-HTTB and manufactured by Jiaxing Tianhe Pharmaceutical Co., Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN MEDCOMTECH.

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