SOLUTION FOR PERFORMANCE EVALUATION OF EQUIPMENT COMPONENTS - ANVISA Registration 10287410105
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 10287410105 and manufactured by ROCHE DIAGNOSTICS. The registration is held by ROCHE DIAGNÓSTICA BRASIL 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
10287410105
25351021704200318
30280358000186
Company Information
Dates and Status
Sep 19, 2003
VIGENTE
09/18/2025 19:00:01
SOLUTION FOR PERFORMANCE EVALUATION OF EQUIPMENT COMPONENTS
ADVIA 120 TESTPOINT CSF CONTROLS
SIEMENS HEALTHACARE DIAGNOSTICS INC
10345160423
Nov 21, 2003
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
FAMÍLIA DE VERIFICADORES DE DESEMPENHO I E II ASO/RF VITROS
ORTHO CLINICAL DIAGNOSTICS, INC
81246986787
Aug 28, 2017
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
ClinCheck® - Control Serum Control lyophilised FOR TRACE ELEMENTS Level II
RECIPE CHEMICALS + INSTRUMENTS GMBH
81086830081
Jul 24, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
ClinCheck® - Control Serum Control lyophilised FOR TRACE ELEMENTS Level I
RECIPE CHEMICALS + INSTRUMENTS GMBH
81086830080
Jul 24, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
FAMÍLIA DE VERIFICADORES DE DESEMPENHO DAT VITROS
ORTHO CLINICAL DIAGNOSTICS, INC
81246980023
Aug 28, 2017
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