BEUDAMED
    FDA Registration Active 🇫🇷 France

    VX650

    Reg #: 3009173773 · FEI: 3009173773 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LUNEAU TECHNOLOGY OPERATIONS
    Registration Number
    3009173773
    FEI Number
    3009173773
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Rue Roger Bonnet
    City
    Pont-de-l'Arche Eure
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K202221

    Owner / Operator

    Firm Name
    LUNEAU TECHNOLOGY OPERATIONS
    Operator Number
    8020811
    Address
    2 Rue Roger Bonnet
    City
    Pont-de-l'Arche
    State
    Eure
    Postal Code
    27340
    Country
    FR

    US Agent

    Business Name
    Visionix USA, Inc
    Contact Name
    Peter G Sparacio
    Address
    160 Eisenhower Ln N
    City
    Lombard
    State
    IL
    ZIP
    60148
    Country
    US
    Email
    [email protected]
    Phone
    630 5090949

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI
    Tonometer, Ac-Powered HKX

    Proprietary Names

    VX650 DNEye Scanner 3

    Establishment Types

    Manufacture Medical Device