BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    3C-Medical Intelligence GmbH

    Reg #: 9710332 · FEI: 3003251135 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    3C-Medical Intelligence GmbH
    Registration Number
    9710332
    FEI Number
    3003251135
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3C-Ring 1
    City
    Landsberg am Lech Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K072898

    Owner / Operator

    Firm Name
    3C-Medical Intelligence GmbH
    Operator Number
    10082856
    Address
    3C-Ring 1
    City
    Landsberg am Lech
    State
    Bavaria
    Postal Code
    86899
    Country
    DE
    Correspondent
    Robert Mitterhauser

    US Agent

    Business Name
    Elekta Inc.
    Contact Name
    Thomas Valentine
    Address
    400 Perimeter Center Terrace, Suite 50
    City
    ATL
    State
    GA
    ZIP
    30346
    Country
    US
    Email
    [email protected]
    Phone
    404 7972537

    Products

    Device Name Product Code
    Couch, Radiation Therapy, Powered JAI
    Accelerator, Linear, Medical IYE
    Table, Radiographic, Stationary Top IXQ
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    HexaPOD BodyFIX BlueBAG iGUIDE iBEAM Fraxion INST 960-539 GUIDE BIOPSY

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)