BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KOWA CO. LTD. CHOFU

    Reg #: 3011223751 · FEI: 3011223751 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    KOWA CO. LTD. CHOFU
    Registration Number
    3011223751
    FEI Number
    3011223751
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-1, Chofugaoka 3-chome
    City
    Chofu Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K112330

    Owner / Operator

    Firm Name
    KOWA CO. LTD.
    Operator Number
    8030217
    Address
    4-14, Nihonbashi-honcho 3-chome, Chuo-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    1038433
    Country
    JP

    US Agent

    Business Name
    Kowa Pharmaceuticals America, Inc.
    Contact Name
    Kraig McBride
    Address
    530 Industrial Park Blvd
    City
    Montgomery
    State
    AL
    ZIP
    36117
    Country
    US
    Email
    [email protected]
    Phone
    334 2881288

    Products

    Device Name Product Code
    System, Image Management, Ophthalmic NFJ
    Camera, Ophthalmic, Ac-Powered HKI
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Perimeter, Automatic, Ac-Powered HPT
    Ophthalmoscope, Laser, Scanning MYC
    Tonometer, Manual HKY

    Proprietary Names

    KOWA VX-20 KOWA SL-17 KOWA VX-10a KOWA nonmyd WX KOWA SL-19 KOWA AP-7000 KOWA GENESIS-Df KOWA FM-600 KOWA APPLANATION TONOMETER HA-2 KOWA APPLANATION TONOMETER HA-1 KOWA VK-2s KOWA nonmyd 8 KOWA DR-1a KOWA GENESIS-D

    Establishment Types

    Manufacture Medical Device