Vietnam MOH registration 2403301ĐKLH/BYT-HTTB

Monocyte Separation Kit with 02 Collection Bags

VN: Bộ tách tiểu cầu kim đơn với 02 túi thu nhận tiểu cầu

Vietnam·Risk Class TTBYT Loại C·AmiCORE Apheresis Kit – Single Needle with Two Platelet Containers; PAS connector·Fenwal International, Inc.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403301ĐKLH/BYT-HTTB
Submission ID: 19009065/ĐKLH-BYT-TB-CT
Product Type: AmiCORE Apheresis Kit – Single Needle with Two Platelet Containers; PAS connector
Product Code: P6R8884

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 AmiCore compatible blood component separation kit for the collection of platelets and plasma on demand.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Monocyte Separation Kit with 02 Collection Bags 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 2403301ĐKLH/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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