BEUDAMED
    Authorized Representative 🇩🇪 Germany Active

    Abiomed Europe GmbH

    SRN: DE-AR-000005280 · Neuenhofer Weg 3, 52074 Aachen, Germany
    View on EUDAMED
    Manufacturers
    1
    Devices
    13
    Certificates
    5
    PRRCs
    2

    Basic Information

    Address
    Neuenhofer Weg 3, 52074 Aachen, Germany
    Email
    [email protected]
    Phone
    +49 241 8860-0
    VAT Number
    DE813647191
    Trade Register
    4260113630006
    EORI
    4978927

    Non-EU Manufacturers

    Name
    Abiomed Inc.

    Manufacturers

    Abiomed Inc.

    Manufacturer
    🇺🇸 United States·11 Basic UDI-DIs·13 Devices·1 Importer·DNV MEDCERT GmbH, DNV MEDCERT GmbH, DNV MEDCERT GmbH, DNV MEDCERT GmbH, and DNV MEDCERT GmbH

    Certificates

    Type Number
    MDD Annex V 2817GB415210518A
    MDD Annex II (excluding section 4) 2817GB410190207
    MDD Annex II Section 4 11931GB411191211A
    MDD Annex II Section 4 11934GB411190716
    MDD Annex II Section 4 11935GB411190920

    Devices

    Impella Purge Cassette

    Device
    EU MDR · Eu Md Class 2a ·Abiomed Inc.·On the market·18 countries

    Impella Purge Cassette

    Device
    EU MDR · Eu Md Class 2a ·Abiomed Inc.·On the market·18 countries

    Impella Purge Cassette

    Device
    EU MDR · Eu Md Class 2a ·Abiomed Inc.·On the market·1 country

    CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·Abiomed Inc.·On the market·19 countries

    CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·Abiomed Inc.·On the market·9 countries

    CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 2a ·Abiomed Inc.·On the market·8 countries

    CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 2a ·Abiomed Inc.·On the market·19 countries

    CARDIOVASCULAR GUIDEWIRES - ACCESSORIES

    Device
    EU MDD · Eu Md Class 2a ·Abiomed Inc.·On the market·19 countries

    CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

    Device
    EU MDD · Eu Md Class 2a ·Abiomed Inc.·On the market·19 countries

    VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER

    Device
    EU MDD · Eu Md Class 2b ·Abiomed Inc.·On the market·19 countries

    Impella 5.0

    Device
    EU MDD · Eu Md Class 3 ·Abiomed Inc.·On the market·15 countries

    Impella RP

    Device
    EU MDD · Eu Md Class 3 ·Abiomed Inc.·On the market·19 countries

    Impella 5.5 with SmartAssist

    Device
    EU MDD · Eu Md Class 3 ·Abiomed Inc.·On the market·6 countries