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    FDA Registration Active 🇩🇪 Germany

    CARL ZEISS MEDITEC AG (JENA)

    Reg #: 3038356864 · FEI: 3038356864 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    78
    Establishment Types
    4
    Classifications
    24

    Registration Details

    Registration Name
    CARL ZEISS MEDITEC AG (JENA)
    Registration Number
    3038356864
    FEI Number
    3038356864
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Goeschwitzer Strasse 51-52
    City
    JENA Thuringia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K032799
    PMA Number
    P060004

    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
    Tonometer, Ac-Powered HKX
    Powered Laser Surgical Instrument GEX
    Laser, Ophthalmic HQF
    Refractometer, Ophthalmic HKO
    System, Image Management, Ophthalmic NFJ
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Excimer Laser System LZS
    Camera, Ophthalmic, Ac-Powered HKI
    Device, Storage, Images, Ophthalmic NFF
    Device, Communications, Images, Ophthalmic NFG
    Ophthalmoscope, Battery-Powered HLJ
    Tomography, Optical Coherence OBO
    Chart, Visual Acuity HOX
    Medical Device Data System OUG
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Microscope, Surgical EPT
    Marker, Ocular HMR
    Topographer, Corneal, Ac-Powered MMQ
    Light, Examination, Medical, Battery Powered KYT
    Keratome, Ac-Powered HNO
    Instrument, Measuring, Lens, Ac-Powered HLM
    Refractor, Manual, Non-Powered, Including Phoropter HKN
    Femtosecond Laser System For Refractive Correction OTL
    Tonometer, Manual HKY

    Proprietary Names

    VISUPLAN 500 VISULAS Trion VISULAS Trion Laser System with the VITE Option VISUREF 150 WASCA Analyzer VISUREF 100 (URK-800) FORUM GLAUCOMA WORKPLACE IOLMaster 500 CALLISTO eye IOL Master 700 IOLMASTER 500 VISULAS combi VISULAS green (classic and comfort) MEL 80 EXCIMER LASER SYSTEM MEL 90 VISULAS yag VISUPAC 481 FF450 Plus VISUPAC System ZEISS Slit Lamp SL 115 ZEISS Slit Lamp SL 120 ZEISS Slit Lamp HSO 10 ZEISS 20 SL Slit Lamp and Mechanical Micromanipulator FORUM Archive and Viewer FORUM Archive IOLMaster 700 (TK) Indirect Ophthalmoscope SL 115, SL 120, SL cam 5 Digital Imaging VISULAS YAG III CIRRUS Photo Models 600 and 800 VISUCAM C Digital Camera VISULAS 532s Laser System with the VITE Option VISUSCREEN 100/500 VISULAS 532s Visulas YAG II Plus Ophthalmic Laser Ophthalmic TRENION 3D HD MEDIALINK 100 EDIS / IDIS VISUConnect500 VISUHEALTH VERACITY surgical SL Imaging Solution IOLMASTER 500 with Option Reference Image IOLMASTER 500 with Reference Image mode Zeiss Cataract Suite Markerless VISULAS green SL 800 Sl 200 i.Profiler Plus ATLAS 500 EyeMag Light II IOL Master Zeiss 30 SL-L Zeiss Slit Lamp SL 130 VisuMax Laser Keratome ZEISS VISULAS YAG II Laser FORUM Assist match VISUCAM Pro NM FAF VISUCAM 224 VISUCAM 524 VISUCAM NM/FA FAF VISUCAM NM/FA VISUCAM ProNM FORUM Viewer App VisuMax (HORUS) LASER KERATOME VISULENS 500 VISULENS 550 Model 350, 355, 360 Humphrey Lens Analyzer Series VisuScout 100 VISUPHOR 500 Visumax Femtosecond Laser VISUMAX 800 FORUM Glaucoma Workplace AT 030 ZEISS VISULAS Argon Laser Retina Workplace CIRRUS photo Models 600 and 800

    Establishment Types

    Foreign Private Label Distributor Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device