BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    RODENSTOCK CR S.R.O.

    Reg #: 3008396732 · FEI: 3008396732 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    RODENSTOCK CR S.R.O.
    Registration Number
    3008396732
    FEI Number
    3008396732
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dr. Sedlaka 841
    City
    Plzensky Klatovy
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K202221

    Owner / Operator

    Firm Name
    Rodenstock GmbH
    Operator Number
    10091286
    Address
    Elsenheimer Strasse 33
    City
    Munich
    State
    DE-NOTA
    Postal Code
    D-80687
    Country
    DE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177 ext. 200

    Products

    Device Name Product Code
    Tonometer, Ac-Powered HKX
    Camera, Ophthalmic, Ac-Powered HKI
    Lens, Spectacle, Non-Custom (Prescription) HQG

    Proprietary Names

    DNEye Scanner 2+, DNEye Scanner 2, VX120, VX118 DNEye Scanner 3 (HKI)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device