BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EXCOR Pediatric Ventricular Assist Device

    Reg #: 3004582654 · FEI: 3004582654 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BERLIN HEART GMBH
    Registration Number
    3004582654
    FEI Number
    3004582654
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Wiesenweg 10, Steglitz
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    PMA Number
    H100004

    Owner / Operator

    Firm Name
    Berlin Heart GmbH
    Operator Number
    10039961
    Address
    Weisenweg 10, Steglitz
    City
    Berlin
    State
    DE-BE
    Postal Code
    D-12247
    Country
    DE

    US Agent

    Business Name
    Berlin Heart, Inc.
    Contact Name
    Robert Kroslowitz
    Address
    9391 Grogans Mill Road, Suite A6
    City
    The Woodlands
    State
    TX
    ZIP
    77380
    Country
    US
    Email
    [email protected]
    Phone
    281 8639700

    Products

    Device Name Product Code
    Ventricular (Assist) Bypass DSQ
    Pediatric Ventricular Assist Device PCK

    Proprietary Names

    EXCOR Pediatric Ventricular Assist Device

    Establishment Types

    Manufacture Medical Device