BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    GE 1.5 Excite HDXT 16X MRI System

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

    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
    K041476

    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
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    GE 1.5 Excite HDXT 16X MRI System

    Establishment Types

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