BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FCI OPHTHALMICS, INC.

    Reg #: 1225124 · FEI: 3000210020 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FCI OPHTHALMICS, INC.
    Registration Number
    1225124
    FEI Number
    3000210020
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    30 Corporate Park Drive, Suite #310/320
    City
    Pembroke
    State
    MA
    ZIP
    02359
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212741
    PMA Number
    P010059

    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

    Products

    Device Name Product Code
    Ring, Endocapsular MRJ
    Implant, Eye Sphere HPZ
    Plug, Punctum LZU

    Proprietary Names

    Morcher CTR EZYPOR FCI Prolong Plug

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198