BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Integre LP5532

    Reg #: 3013515803 · FEI: 3002806902 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    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
    K052777

    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
    Powered Laser Surgical Instrument GEX
    Laser, Ophthalmic HQF

    Proprietary Names

    Integre LP5532 Integre Pro LP1RG

    Establishment Types

    Manufacture Medical Device