BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    Gründler GmbH

    Manufacturer
    🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY

    Fiagon GmbH

    Manufacturer
    🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY

    PAUSCH Medical GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

    Rhyk Technologies GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·February 11, 2015

    FI24/00000064

    Certificate
    MDR QMS·Fiagon GmbH·SGS FIMKO OY

    FI23/00000052

    Certificate
    MDR QMS·PAUSCH Medical GmbH·SGS FIMKO OY

    FI23/00000046

    Certificate
    MDR QMS·Rhyk Technologies GmbH·SGS FIMKO OY

    FI23/00000013

    Certificate
    MDR QMS·Gründler GmbH·SGS FIMKO OY