BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OKAMOTO INDUSTRIES, INC.

    Reg #: 3006122980 · FEI: 3006122980 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    OKAMOTO INDUSTRIES, INC.
    Registration Number
    3006122980
    FEI Number
    3006122980
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO.1, NISHIYAMA-ITABASHI-CHO,
    City
    RYUGASAKI-SHI, IBARAKI-PREF
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K203541

    Owner / Operator

    Firm Name
    OKAMOTO INDUSTRIES, INC.
    Operator Number
    8031642
    Address
    27-12, 3-CHOME HONGO,, BUNKYO-KU
    City
    TOKYO
    State
    JP-NOTA
    Postal Code
    113-8710
    Country
    JP

    US Agent

    Business Name
    Okamoto U.S.A., Inc.
    Contact Name
    Hisayuki Naito
    Address
    18 King St.
    City
    Stratford
    State
    CT
    ZIP
    06615
    Country
    US
    Email
    [email protected]
    Phone
    203 3780003 ext. 305

    Products

    Device Name Product Code
    Condom, Synthetic MOL
    Condom HIS
    Pack, Hot Or Cold, Disposable IMD

    Proprietary Names

    WINK Slider 04 ZERO ZERO FOUR WINK Closer HEAT THERAPY Beyond BodiHeat

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device