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

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    Filters Country: Germany ×

    IKA-Werke GmbH & Co. KG

    Manufacturer
    🇩🇪 Germany

    Solflex IBT 1000 g

    Device
    EU MDR · Eu Md Class 1 ·DETAX GmbH & Co. KG·On the market·1 country

    Ultraprint-Dental IBT UV 500g

    Device
    EU MDR · Eu Md Class 1 ·DETAX GmbH & Co. KG·Not intended for eu market

    freeprint IBT 385 1000 g

    Device
    EU MDR · Eu Md Class 1 ·DETAX GmbH & Co. KG·On the market·32 countries

    freeprint IBT 385 500 g

    Device
    EU MDR · Eu Md Class 1 ·DETAX GmbH & Co. KG·On the market·32 countries

    Ultraprint-Dental IBT UV 1.000 g

    Device
    EU MDR · Eu Md Class 1 ·DETAX GmbH & Co. KG·Not intended for eu market

    IGT-Tubes Family

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Philips Medical Systems DMC GmbH·8 devices

    Daniels Medizintechnik GmbH&Co.KG

    Importer
    🇩🇪 Germany·1 Manufacturer

    ARTIQO

    Importer
    🇩🇪 Germany·3 Manufacturers

    Daniels Medizintechnik GmbH&Co.KG

    Authorized representative
    🇩🇪 Germany·1 Manufacturer·1 Device

    TRI Dental Implants Direct GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    medddbase Deutschland GmbH

    Importer
    🇩🇪 Germany·5 Manufacturers

    Löwenstein Medical SE & Co. KG

    Importer
    🇩🇪 Germany·6 Manufacturers

    Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c 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·April 24, 2019

    7333DE410190313

    Certificate
    MDD Annex II (excluding section 4)·VISUS Health IT GmbH·DNV MEDCERT GmbH·1 Basic UDI-DI

    StatConsult IT-Service GmbH

    System producer
    🇩🇪 Germany

    The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. The Alinity c 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·August 14, 2019

    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

    inne MINILAB

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Feral GmbH·1 device

    SAMPLING.pro

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·BIOMES NGS GmbH·1 device