SOLUTION FOR PERFORMANCE EVALUATION OF EQUIPMENT COMPONENTS - ANVISA Registration 80015490065
Access comprehensive regulatory information for SOLUTION FOR PERFORMANCE EVALUATION OF EQUIPMENT COMPONENTS in Brazil's medical device market through Pure Global AI's free database. This Risk Class I medical device is registered under ANVISA number 80015490065 and manufactured by SYSMEX CORPORATION. The registration is held by SYSMEX DO BRASIL INDUSTRIA E COMERCIO LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including LIFE TECHNOLOGIES HOLDINGS PTE LTD, LUMINEX CORPORATION, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
80015490065
25351166855200951
02923414000118
Company Information
Dates and Status
Jul 13, 2009
VIGENTE
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
Universal Calibrator - UniCal
ROCHE DIAGNOSTICS GMBH
10287411739
Mar 05, 2025
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
SYSTEM CALIBRATOR
BECKMAN COULTER IRELAND INC.
10033120841
Nov 25, 2013
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
UF II CONTROL
SYSMEX CORPORATION
80015490056
Aug 27, 2007
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
Controles e Calibradores Multiparâmetro, Exclusivos para a Execução de um Ensaio Específico - UF-4000/5000
SYSMEX CORPORATION
80015490114
Sep 12, 2016
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
C.F.A.S. - CALIBRATOR FOR AUTOMATED SYSTEMS
ROCHE DIAGNOSTICS GMBH
10287410378
Nov 09, 2004
LIFE TECHNOLOGIES HOLDINGS PTE LTD• Singapore
LUMINEX CORPORATION• United States of America
BECKMAN COULTER INC.• United States of America
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES• United States of America
ZYBIO INC.• China
SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS
FLEXMAP 3D® Performance Verification Kit
LUMINEX CORPORATION
80003610617
Sep 15, 2025
SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS
FLEXMAP 3D® Calibration Kit
LUMINEX CORPORATION
80003610618
Sep 15, 2025
SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS
MCM Focus
CHANGCHUN MEDICSIDE MEDICAL TECHNOLOGY CO. LTD.
80345000339
Sep 08, 2025
SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS
IVD Bacterial Test Standard
BRUKER DALTONICS GMBH & CO. KG
10033121085
Aug 11, 2025
SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS
Padrão Interno ISE VIDA RI e SI
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.
80785070273
Jul 07, 2025