BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NIDEK INCORPORATED

    Reg #: 2936921 · FEI: 2936921 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NIDEK INCORPORATED
    Registration Number
    2936921
    FEI Number
    2936921
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6601 Cascades Court, Suite 130
    City
    The Colony
    State
    TX
    ZIP
    75056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190198

    Owner / Operator

    Firm Name
    NIDEK CO., LTD.
    Operator Number
    8030392
    Address
    34-14 MAEHAMA, HIROISHI-CHO, --
    City
    GAMAGORI, AICHI
    State
    JP-23
    Postal Code
    4430038
    Country
    JP

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI
    Perimeter, Automatic, Ac-Powered HPT

    Establishment Types

    Manufacture Medical Device