BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    GE Innova 2100-IQ

    Reg #: 3011416394 · FEI: 3011416394 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Medical Resale PTY Limited
    Registration Number
    3011416394
    FEI Number
    3011416394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3/2 Otranto Avenue
    City
    Caloundra QLD Queensland
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K052412

    Owner / Operator

    Firm Name
    Medical Resale PTY Limited
    Operator Number
    10047901
    Address
    3/2 Otranto Avenue
    City
    Caloundra
    State
    Queensland
    Postal Code
    4551
    Country
    AU
    Correspondent
    Dane Shelford

    US Agent

    Business Name
    Medical Resale PTY Ltd
    Contact Name
    Casey Sullivan
    Address
    235 W Woodstone Ct
    City
    Baton Rouge
    State
    LA
    ZIP
    70808
    Country
    US
    Email
    [email protected]
    Phone
    225 7727728

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    GE Innova 2100-IQ

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device