BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Gerresheimer Regensburg GmbH

    Reg #: 3012529833 · FEI: 3012529833 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gerresheimer Regensburg GmbH
    Registration Number
    3012529833
    FEI Number
    3012529833
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oskar-von-Miller-Strasse 6
    City
    Wackersdorf Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K241849

    Owner / Operator

    Firm Name
    Gerresheimer Regensburg GmbH
    Operator Number
    10030618
    Address
    Kumpfmuehlerstrasse 2
    City
    Regensburg
    State
    Bavaria
    Postal Code
    93047
    Country
    DE
    Correspondent
    Paula Schmidt

    US Agent

    Business Name
    Gerresheimer Peachtree City, L.P.
    Contact Name
    Adelaido Angel
    Address
    650 Highway 74 S
    City
    Peachtree City
    State
    GA
    ZIP
    30269
    Country
    US
    Email
    [email protected]
    Phone
    770 5894157

    Products

    Device Name Product Code
    Injector, Contrast Medium, Automatic IZQ

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)