BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carl Zeiss Meditec Cataract Technology Inc

    Reg #: 3012123033 · FEI: 3012123033 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Carl Zeiss Meditec Cataract Technology Inc
    Registration Number
    3012123033
    FEI Number
    3012123033
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8740 Technology Way
    City
    Reno
    State
    NV
    ZIP
    89521
    Country
    US

    Regulatory Submissions

    510(k) Number
    K214028

    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)

    Products

    Device Name Product Code
    Unit, Phacofragmentation HQC
    Vitrectomy, Instrument Cutter MLZ
    Hook, Ophthalmic HNQ

    Proprietary Names

    MICOR Lens Fragmentation System miCOR (xPORT304; miCOR 700 system) miCOR miLOOP SU MACKOOL HOOKS miLOOP reusable MICOR 700 with Auto I/A

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198