Vietnam MOH registration 2402786ĐKLH/BYT-HTTB

Bagged Red Blood Cell Separation Kit

VN: Bộ dụng cụ tách tiểu cầu kim đơn có túi đựng tiểu cầu

Vietnam·Risk Class TTBYT Loại C·Amicus Apheresis Kit –Single Needle·Fenwal International, Inc.·Registered Oct 02, 2024

Registration details

Analysis ID: 2402786ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211102-0002
Product Type: Amicus Apheresis Kit –Single Needle
Product Code: X6R2312

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 kit is designed to be used with the Amicus blood component separation machine for the collection process of platelets, plasma, and red blood cells.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for Bagged Red Blood Cell Separation 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 2402786ĐKLH/BYT-HTTB and manufactured by Fenwal International, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.