BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Ellex Medical Pty Ltd

    Reg #: 3013515803 · FEI: 3002806902 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    Ellex Medical Pty Ltd
    Registration Number
    3013515803
    FEI Number
    3002806902
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-4 Second Avenue
    City
    Mawson Lakes South Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K222395

    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
    Laser, Ophthalmic HQF
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Powered Laser Surgical Instrument GEX
    Table, Instrument, Powered, Ophthalmic HRJ

    Proprietary Names

    Tango Neo Tango Reflex Neo UltraQ Reflex Neo Solitaire Integre Integre Pro LP1RG Integre Pro LP5532 Integre Yellow Pro LP561 Integre Red/Yellow Pro L2RY Integre Pro family Integre Pro Scan Eye Prime Diagnostic ophthalmic ultrasound system Eye Prime Tango LT5106-T Tango Reflex LT5106-T Solo LT5106-S Ultra Q LQP3106-U Ultra Q Reflex LQP3106-U Eye Cubed New Generation Eye Cubed-ABDU Diagnostic Ultrasound Eye Cubed V4 I3 System EYE CUBED System -ABD Diagnostic Ultrasound Eye One Diagnostic Ultrasound System Ellex Total Solution Tables Laserex LQP3106 Coherent Aura Laserex 3000LX Super Q Alcon 3000LE Ultra Q Reflex Tango Reflex Tango Ultra Q Solo Integre LP5532

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device