BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CARL ZEISS MEDITEC AG (Munich)

    Reg #: 3009746052 · FEI: 3009746052 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    CARL ZEISS MEDITEC AG (Munich)
    Registration Number
    3009746052
    FEI Number
    3009746052
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kistlerhof Strasse 75
    City
    Muenchen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K182318

    Owner / Operator

    Firm Name
    Carl Zeiss Meditec AG (Jena)
    Operator Number
    9053564
    Address
    Goeschwitzer Strasse 51-52
    City
    Jena
    State
    Thuringia
    Postal Code
    07745
    Country
    DE
    Correspondent
    Carl ZEISS Meditec AG (Jena)

    US Agent

    Business Name
    CARL ZEISS MEDITEC USA, INC.
    Contact Name
    Paul Swift
    Address
    5300 Central Pkwy
    City
    Dublin
    State
    CA
    ZIP
    94568
    Country
    US
    Email
    [email protected]
    Phone
    817 9258507

    Products

    Device Name Product Code
    Tomography, Optical Coherence OBO
    Camera, Ophthalmic, Ac-Powered HKI
    System, Image Management, Ophthalmic NFJ
    System, Digital Image Communications, Radiological LMD
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Microscope, Surgical EPT
    Marker, Ocular HMR
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Device, Communications, Images, Ophthalmic NFG

    Proprietary Names

    Retina Workplace Retina Workplace 2 CALLISTO eye Panel PC FORUM Archive and Viewer FORUM Assist match FORUM Archive IOLMASTER 500 with Option Reference Image IOLMASTER 500 with Reference Image mode Zeiss Cataract Suite Markerless FORUM FORUM Viewer App FORUM Glaucoma Workplace FORUM GLAUCOMA WORKPLACE CALLISTO eye CALLISTO EYE

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility