BEUDAMED
    8 results · 60ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    1319681-2018-00093

    FDA Adverse Event
    Malfunction ·September 12, 2018

    VITROS 5600 INTEGRATED SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·January 2, 2019

    VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·June 4, 2010

    HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code JMT·May 22, 2023

    CEpartner4U

    Authorized representative
    🇳🇱 Netherlands·160 Manufacturers·5787 Devices

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices