Automated Cell Separation and Manufacturing System - Vietnam Registration 2402051ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2402051ĐKLH/BYT-HTTB
000.00.04.G18-230307-0027
CliniMACS Prodigy
200-075-301
Technical Details
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
Aug 27, 2024