Vietnam MOH registration 2400473ĐKLH/BYT-HTTB

Leukocyte-filtering platelet separator

VN: Bộ tách tiểu cầu có lọc bạch cầu

Vietnam·Risk Class TTBYT Loại C·BioP flex Pool·Fresenius HemoCare Italia S.r.l.·Registered Apr 10, 2024

Registration details

Analysis ID: 2400473ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211117-0001
Product Type: BioP flex Pool
Product Code: A2CE0701

Company information

Manufacturer: Fresenius HemoCare Italia S.r.l.
Manufacturer Country: ITALY
Product Owner: Fresenius Medical Care
Authorized Representative: CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM

Technical details

Intended Use: Used for the filtration of buffy coat clumps (comprising 4 to 6 units of buffy coat) by an automated or semi-automated process. The Pool type with a sealed tube format is used for sterile connections.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for Leukocyte-filtering platelet separator 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 2400473ĐKLH/BYT-HTTB and manufactured by Fresenius HemoCare Italia S.r.l.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM.

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