BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    Elis Nordost GmbH

    Manufacturer
    🇩🇪 Germany

    Elis Ost GmbH

    Manufacturer
    🇩🇪 Germany

    Elis West GmbH

    Manufacturer
    🇩🇪 Germany

    LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 1, 2020

    ELOS GmbH & Co. KG

    Importer
    🇩🇪 Germany

    ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·RECIPE Chemicals + Instruments GmbH·1 device

    ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma by UHPLC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·RECIPE Chemicals + Instruments GmbH·1 device

    Contact Lens Service GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    SEED Contact Lens Europe GmbH

    Authorized representative
    🇩🇪 Germany·2 Manufacturers

    Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (LN 03R67 01) processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·May 22, 2019

    KTR Europe GmbH

    Authorized representative
    🇩🇪 Germany·135 Manufacturers·3461 Devices