BEUDAMED
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    Kent Imaging Inc.

    Manufacturer
    🇨🇦 Canada

    Kent Imaging Inc

    FDA registration
    Kent Imaging Inc·4 products·🇨🇦 Canada

    SnapshotNIR

    FDA UDI
    Kent Imaging Inc·B376KD2050·Tissue oxygenation imaging device

    SnapshotNIR

    FDA UDI
    Kent Imaging Inc·B376KD2040·Tissue oxygenation imaging device

    Drape KB100 Series

    FDA UDI
    Kent Imaging Inc·B376KB100D0·Drapes designed to limit light exposure from th...

    SnapshotGLO

    FDA UDI
    Kent Imaging Inc·B376KB1000·The SnapshotGLO is a portable, non-invasive opt...

    Snapshot NIR, REF: KD204

    FDA Recall
    Open, Classified ·KENT IMAGING, INC.·Product code MUD·October 30, 2023

    Snapshot NIR, REF: KD204

    FDA Enforcement
    Class II ·Ongoing·KENT IMAGING, INC.·January 31, 2024

    GORE-TEX® SUTURE

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code GAW·December 16, 2024

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices