BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ABIOMED EUROPE GMBH

    Reg #: 3007904765 · FEI: 3007904765 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ABIOMED EUROPE GMBH
    Registration Number
    3007904765
    FEI Number
    3007904765
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Neuenhofer Weg 3
    City
    Aachen North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    PMA Number
    P170011

    Owner / Operator

    Firm Name
    Abiomed Europe GmbH
    Operator Number
    10030761
    Address
    Neuenhofer Weg 3
    City
    Aachen
    State
    North Rhine-Westphalia
    Postal Code
    52074
    Country
    DE

    US Agent

    Business Name
    Abiomed, Inc.
    Contact Name
    Anshul Shah
    Address
    22 Cherry Hill Drive
    City
    Danvers
    State
    MA
    ZIP
    01923
    Country
    US
    Email
    [email protected]
    Phone
    323 5415318

    Products

    Device Name Product Code
    Temporary Non-Roller Type Right Heart Support Blood Pump PYX
    Temporary Non-Roller Type Left Heart Support Blood Pump OZD

    Proprietary Names

    Impella RP Impella RP Flex with SmartAssist Impella RP with SmartAssist Impella CP Impella 5 Impella LD Impella 2.5

    Establishment Types

    Manufacture Medical Device