BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CARL ZEISS MEDITEC AG (OBERKOCHEN)

    Reg #: 9615010 · FEI: 3003481798 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    111
    Establishment Types
    5
    Classifications
    26

    Registration Details

    Registration Name
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Registration Number
    9615010
    FEI Number
    3003481798
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    RUDOLF-EBER-STRASSE 11
    City
    OBERKOCHEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K232159

    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
    Endoscope, Neurological GWG
    Unit, Phacofragmentation HQC
    Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE
    System, Therapeutic, X-Ray JAD
    Spectacle, Operating (Loupe), Ophthalmic HOH
    System, Image Management, Ophthalmic NFJ
    Microscope, Surgical EPT
    Marker, Ocular HMR
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Camera, Surgical And Accessories KQM
    Tomography, Optical Coherence OBO
    Drape, Microscope, Ophthalmic HMW
    Drape, Surgical, Exempt PUI
    Diagnostic Neurosurgical Microscope Filter QFX
    Confocal Optical Imaging OWN
    System, Image Processing, Radiological LLZ
    Chair And Table, Medical KMN
    System, Digital Image Communications, Radiological LMD
    System, X-Ray, Angiographic IZI
    Colposcope (And Colpomicroscope), Exempt PTZ
    Instrument, Quality-Assurance, Radiologic LHO
    Medical Device Data System OUG
    Instrument, Measuring, Lens, Ac-Powered HLM
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Microscope, Surgical, General & Plastic Surgery FSO
    Hook, Ophthalmic HNQ

    Proprietary Names

    QEVO System QUATERA 700 INTRABEAM EyeMag Pro F (with accessories) EyeMag Smart (with accessories) EyeMag Classic EyeMag SMART TTL EyeMag Pro S (with accessories) INTRABEAM Balloon Applicator and CBG Sets CALLISTO eye CALLISTO EYE VISALIS 500 S88 / OPMI Lumera T S8/OPMI VISU 200 S100 / OPMI pico i RESIGHT 500 (with acccessories) RESIGHT 700 (with accessories) S8 / OPMI Lumera T S7 / OPMI VISU 160 S81 / OPMI Lumera T S7 / OPMI Lumera S7 / OPMI VISU 140 OPMI Lumera 700 OPMI 1 FR pro ARTEVO 800 UC 3D Digital Upgrade Kit S8/OPMI VISU 160 S8/OPMI VISU 210 OPMI Lumera i S81/OPMI VISU 160 S88/OPMI VISU 160 S88/OPMI VISU 210 S81/OPMI VISU 210 ARTEVO 750/850 Single-use lenses for RESIGHT OPMI Lumera 300 1 Chip HD Camera MediLive Trio Eye Sony HD Recorder HVO-500MD ZEISS Connect App MediLive 1 CCD TRIO 620 with CCU TRIO 600 MediLive TRIO 610 with CCU TRIO 600 MediLive Primo MediLive Trio dent TRIO 630 with CCU TRIO 600 MediLive Trio RESCAN 700, CALLISTO eye INTRABEAM System with Spherical Applicator Asepsis VISULUX Metal Sleeves INTRABEAM System with Needle Applicator VisionGuard Lens Protectors OPMI Drape DRAPES Sterile OPMI Drape Sterile Foot Switch Drapes Drapes SMARTDRAPE VisionGuard Replacement Lenses INTRABEAM Drape Asepsis Caps INTRABEAM SMARTDRAPE SMARTDRAPE Replacement Lenses INTRABEAM 600 BLUE 400 QUATERA 700 and Accessories CONVIVO In ViVo Pathology Suite INTRABEAM System with Flat Applicator INTRABEAM System with Surface Applicator NC 32 INTRABEAM Floor Stand INTRABEAM Cart FORUM Archive and Viewer FORUM Archive CALLISTO eye Panel PC YELLOW 560 Fluorescence Module Kolposkop E KSK 150 FC INTRABEAM Water Phantom Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) TRENION 3D HD MEDIALINK 100 EDIS / IDIS VISUConnect500 VISUHEALTH VERACITY surgical SL Imaging Solution INTRABEAM (700) INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator CONVIVO INFRARED VISULENS 500 VISULENS 550 Model 350, 355, 360 Humphrey Lens Analyzer Series VISULUX QEVO System with KINEVO 900 BLUE 400 S OPMI PENTERO 800 and accessories S7 / OPMI PROergo and accessories S7 / OPMI Sensera and accessories S100 / OPMI pico and accessories KINEVO 900 and accessories TIVATO 700 and accessories OPMI PENTERO 900 and accessories PENTERO 800 S KINEVO 900 S miLOOP SU MACKOOL HOOKS miLOOP reusable

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198