BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Ultra Q

    Reg #: 3013515803 · FEI: 3002806902 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    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
    K212630

    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

    Proprietary Names

    Ultra Q Tango Tango Reflex Ultra Q Reflex Solo

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device