BEUDAMED
    113 results · 23ms · Sources: EU EUDAMED, US FDA

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    LDN Labor Diagnostika Nord GmbH & Co. KG

    Manufacturer
    🇩🇪 Germany

    Biotech GmbH

    Manufacturer
    🇩🇪 Germany·12 Basic UDI-DIs·12 Devices·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC), NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC), NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC), NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC), and NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)

    Inuvet GmbH

    Manufacturer
    🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)

    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

    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

    Biotech Modular Shoulder System (BMS)

    Device
    EU MDD · Eu Md Class 3 ·Biotech GmbH·On the market·3 countries

    Biotech Sterile Knee Endoprosthesis Systems

    Device
    EU MDD · Eu Md Class 3 ·Biotech GmbH·On the market·6 countries

    Biotech Sterile Hip Endoprosthesis Systems

    Device
    EU MDD · Eu Md Class 3 ·Biotech GmbH·On the market·7 countries

    Instruments and Trial Tray for Biotech Modular Shoulder System (BMS)

    Device
    EU MDD · Eu Md Class 2a ·Biotech GmbH·On the market·3 countries

    Trial and Instrument accessories for Biotech Traumatological Implant Systems for Osteosynthesis

    Device
    EU MDD · Eu Md Class 2a ·Biotech GmbH·On the market·3 countries

    Trial and Instrument accessories for Biotech Spinal Implant System

    Device
    EU MDD · Eu Md Class 2a ·Biotech GmbH·On the market·3 countries

    Trial and Instrument accessories for Biotech Pectus Bar Correct System

    Device
    EU MDD · Eu Md Class 2a ·Biotech GmbH·On the market·3 countries

    Instruments and Trial Tray for Biotech Sterile Knee Endoprosthesis Systems

    Device
    EU MDD · Eu Md Class 2a ·Biotech GmbH·On the market·6 countries

    Instruments and Trial Tray for Biotech Sterile Hip Endoprosthesis Systems

    Device
    EU MDD · Eu Md Class 2a ·Biotech GmbH·On the market·7 countries

    Biotech Traumatological Implant Systems for Osteosynthesis

    Device
    EU MDD · Eu Md Class 2b ·Biotech GmbH·On the market·3 countries

    Biotech Spinal Implant System

    Device
    EU MDD · Eu Md Class 2b ·Biotech GmbH·On the market·3 countries

    Biotech Pectus Bar Correct System

    Device
    EU MDD · Eu Md Class 2b ·Biotech GmbH·On the market·3 countries

    ManukaLind Ointment

    Device
    EU MDD · Eu Md Class 2b ·Inuvet GmbH·On the market·12 countries

    ManukaLind Patches

    Device
    EU MDD · Eu Md Class 2b ·Inuvet GmbH·On the market·12 countries

    ManukaLind Ointment 15 g

    Device
    EU MDD · Eu Md Class 2b ·Inuvet GmbH·On the market·12 countries