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

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    ARC 400

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HSC-Medical GmbH

    Importer
    🇩🇪 Germany·3 Manufacturers

    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·October 11, 2023

    KTR Europe GmbH

    Authorized representative
    🇩🇪 Germany·135 Manufacturers·3461 Devices

    mdi Europa GmbH

    Authorized representative
    🇩🇪 Germany·132 Manufacturers·4741 Devices