BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EIZO GmbH

    Reg #: 3006615345 · FEI: 3006615345 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EIZO GmbH
    Registration Number
    3006615345
    FEI Number
    3006615345
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Carl-Benz-Strasse 3
    City
    Ruelzheim Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K112645

    Owner / Operator

    Firm Name
    EIZO GmbH
    Operator Number
    10022828
    Address
    Carl-Benz-Strasse 3
    City
    Ruelzheim
    State
    Rhineland-Palatinate
    Postal Code
    76761
    Country
    DE
    Correspondent
    Anya Caliebe

    US Agent

    Business Name
    EIZO Inc.
    Contact Name
    Thomas Waletzki
    Address
    5710 Warland Drive
    City
    Cypress
    State
    CA
    ZIP
    90630
    Country
    US
    Email
    [email protected]
    Phone
    562 4315011

    Products

    Device Name Product Code
    Camera, Surgical And Accessories KQM
    Display, Cathode-Ray Tube, Medical DXJ

    Proprietary Names

    EX5841-KS CuratOR EX5841 CuratOR EX4342 CuratOR EX5542 CuratOR EX4942 CuratOR EX4342-3D TM442 RadiForce Large Monitor System

    Establishment Types

    Manufacture Medical Device