BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Revi Implant

    Reg #: 3003923762 · FEI: 3003923762 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSYPKA AG
    Registration Number
    3003923762
    FEI Number
    3003923762
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Earl-H.-Wood-Str. 1
    City
    Rheinfelden Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    DEN220073

    Owner / Operator

    Firm Name
    Osypka AG
    Operator Number
    10048738
    Address
    Earl-H.-Wood-Str. 1
    City
    Rheinfelden
    State
    Baden-Wurttemberg
    Postal Code
    79618
    Country
    DE
    Correspondent
    Nicola Osypka

    US Agent

    Business Name
    Alan VanHouten Biomedical Consulting
    Contact Name
    Alan VanHouten
    Address
    916 Ridgecrest Drive
    City
    Carver
    State
    MN
    ZIP
    55315
    Country
    US
    Email
    [email protected]
    Phone
    952 3932987

    Products

    Device Name Product Code
    Implanted Tibial Electrical Urinary Continence Device QXM

    Proprietary Names

    Revi Implant

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)