BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Eye Cubed-ABDU Diagnostic Ultrasound

    Reg #: 3013515803 · FEI: 3002806902 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ellex Medical Pty Ltd
    Registration Number
    3013515803
    FEI Number
    3002806902
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-4 Second Avenue
    City
    Mawson Lakes South Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K103608

    Owner / Operator

    Firm Name
    Ellex Medical
    Operator Number
    9010469
    Address
    3-4 Second Avenue, --
    City
    Mawson Lakes
    State
    South Australia
    Postal Code
    5095
    Country
    AU

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Eye Cubed-ABDU Diagnostic Ultrasound I3 System Eye Cubed V4 Eye Cubed New Generation Eye One Diagnostic Ultrasound System EYE CUBED System -ABD Diagnostic Ultrasound

    Establishment Types

    Manufacture Medical Device