BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carl Zeiss Meditec Production, LLC.

    Reg #: 3010126268 · FEI: 3010126268 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Carl Zeiss Meditec Production, LLC.
    Registration Number
    3010126268
    FEI Number
    3010126268
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1040 S VINTAGE AVE BLDG A
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123888
    PMA Number
    P100016

    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
    Intraocular Lens HQL
    Folders And Injectors, Intraocular Lens (Iol) MSS

    Proprietary Names

    CT LUCIA 601P CT LUCIA 202 CT LUCIA 211P CT LUCIA 201PY CT LUCIA 201P CT LUCIA 611P CT LUCIA 611PY CT LUCIA 211PY CT LUCIA 601PY CT LUCIA 621PY CT LUCIA 221P CT LUCIA 621P intraocular lens CT LUCIA 602 Z CARTRIDGE IOL DELIVERY SYSTEM

    Establishment Types

    Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device