BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EmpowerMR Injector System

    Reg #: 3001427085 · FEI: 3001427085 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BYTEC MEDIZINTECHNIK GMBH
    Registration Number
    3001427085
    FEI Number
    3001427085
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hermann-Hollerith-Str. 11
    City
    Eschweiler North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K062449

    Owner / Operator

    Firm Name
    BYTEC MEDIZINTECHNIK GMBH
    Operator Number
    10023741
    Address
    Hermann-Hollerith-Str. 11
    City
    Eschweiler
    State
    North Rhine-Westphalia
    Postal Code
    52249
    Country
    DE
    Correspondent
    Paul-Willi Coenen

    US Agent

    Business Name
    ACIST Medical Systems, Inc.
    Contact Name
    Jonathan Watkins
    Address
    7905 Fuller Road
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    651 8558002

    Products

    Device Name Product Code
    Injector, Contrast Medium, Automatic IZQ

    Proprietary Names

    EmpowerMR Injector System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)