BEUDAMED
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    COBAS C 311 ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 26, 2024

    ELECSYS CHAGAS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code QHM·August 9, 2024

    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

    FDA Enforcement
    Class II ·Ongoing·Wiener Laboratories·March 14, 2018

    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

    FDA Recall
    Open, Classified ·Wiener Laboratories Street Riobamba Argentina·Product code MIU·November 10, 2017

    Wiener Laboratorios SAIC

    Manufacturer
    🇦🇷 Argentina

    WIENER LABORATORIOS S.A.I.C.

    FDA registration
    WIENER LABORATORIOS S.A.I.C.·50 products·🇦🇷 Argentina

    Medical Technology Promedt Consulting GmbH

    Authorized representative
    🇩🇪 Germany·194 Manufacturers·10009 Devices

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices

    ROBE MEDICAL

    Importer
    🇫🇷 France·64 Manufacturers