BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    DNEye Scanner 2

    Reg #: 3003771740 · FEI: 3003771740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VISIONIX LTD.
    Registration Number
    3003771740
    FEI Number
    3003771740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    TECHNOLOGY PARK, MANHAT 98
    City
    JERUSALEM
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K143086

    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
    Tonometer, Ac-Powered HKX

    Proprietary Names

    DNEye Scanner 2 VX120+ DNEye Scanner 2+ VX120 VX220 VX118

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)