BEUDAMED
    FDA Registration Active 🇨🇱 Chile

    DNEye Scanner 3 (HKI)

    Reg #: 3004848970 · FEI: 3004848970 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Industria Optica Rodenstock Chile S. A
    Registration Number
    3004848970
    FEI Number
    3004848970
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenida Beaucheff N 1581 Santiago
    City
    Santiago , Region Metropolitana
    Country
    CL

    Regulatory Submissions

    510(k) Number
    K202221

    Owner / Operator

    Firm Name
    Rodenstock GmbHElsenheimer
    Operator Number
    10061326
    Address
    Elsenheimer Strasse 33
    City
    Munich
    State
    Bavaria
    Postal Code
    80687
    Country
    DE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    DNEye Scanner 3 (HKI)

    Establishment Types

    Manufacture Medical Device