BEUDAMED
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    HENORA 300PSI I.V. CATHETER EXTENSION SET

    FDA Adverse Event
    Malfunction ·RGI MEDICAL MANUFACTURING INC.·Product code GCD·March 14, 2014

    HENORA 300PSI I.V. CATHETER EXTENSION SET

    FDA Adverse Event
    Malfunction ·RGI MEDICAL MANUFACTURING INC.·Product code GCD·March 20, 2014

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    FDA Recall
    Terminated ·RGI Medical Manufacturing, Inc.·Product code FPA·March 28, 2014

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    FDA Enforcement
    Class II ·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    PureCE B.V.

    Authorized representative
    🇳🇱 Netherlands·38 Manufacturers·468 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Duomed Scandinavia A/S

    Importer
    🇩🇰 Denmark·23 Manufacturers

    Lohmann & Rauscher International GmbH & Co. KG

    Importer
    🇩🇪 Germany·23 Manufacturers

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices