BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOVA EYE INC.

    Reg #: 3005641545 · FEI: 3005641545 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    NOVA EYE INC.
    Registration Number
    3005641545
    FEI Number
    3005641545
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    41316 Christy St
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221872

    Owner / Operator

    Firm Name
    Nova Eye Medical Ltd
    Operator Number
    10075633
    Address
    107 Rundle Street
    City
    Kent Town
    State
    South Australia
    Postal Code
    5067
    Country
    AU
    Correspondent
    Don Watton

    Products

    Device Name Product Code
    Endoilluminator MPA
    Cannula, Ophthalmic HMX
    Pump, Infusion, Ophthalmic MRH

    Proprietary Names

    iTrack Advance Viscoinjector Canaloplasty Microcather iTrack 250A iLumin

    Establishment Types

    Manufacture Medical Device