Vietnam MOH registration 2402051ĐKLH/BYT-HTTB

Automated Cell Separation and Manufacturing System

VN: Hệ thống tách và sản xuất tế bào tự động

Vietnam·Risk Class TTBYT Loại C·CliniMACS Prodigy·Miltenyi Biotec B.V & Co. KG·Registered Aug 27, 2024

Registration details

Analysis ID: 2402051ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230307-0027
Product Type: CliniMACS Prodigy
Product Code: 200-075-301

Company information

Manufacturer: Miltenyi Biotec B.V & Co. KG
Manufacturer Country: GERMANY
Product Owner: Miltenyi Biotec B.V & Co. KG
Authorized Representative: CÔNG TY TNHH B.C.E VIỆT NAM

Technical details

Intended Use: 1. The CliniMACS Prodigy Cell Separation System, which includes the CliniMACS Prodigy Components, CliniMACS Reagent Chemicals, CliniMACS Prodigy Pipette Set, CliniMACS PBS/EDTA Buffer and other accessories used in combination, is designed for in vitro separation of specific cells for clinical applications. 2. The CliniMACS Prodigy System for Gene Therapy and Cell Therapy is intended for use in ex vivo genetic manipulation and/or important cell manipulations in humans or for the manufacture of an Advanced Therapy Medicinal Product (ATMP) for clinical applications.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Automated Cell Separation and Manufacturing System 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 2402051ĐKLH/BYT-HTTB and manufactured by Miltenyi Biotec B.V & Co. KG. The authorized representative in Vietnam is CÔNG TY TNHH B.C.E VIỆT NAM.

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