BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    VA370LUXNA

    Reg #: 3010373292 · FEI: 3010373292 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TAIYO KOGYO CO., LTD. HANYU TECHNICAL PLANT
    Registration Number
    3010373292
    FEI Number
    3010373292
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-45 Ohnuma
    City
    Hanyu Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K113717

    Owner / Operator

    Firm Name
    TAIYO KOGYO CO., LTD. HANYU TECHNICAL PLANT
    Operator Number
    10086964
    Address
    2-45 Ohnuma
    City
    Hanyu
    State
    Saitama
    Postal Code
    348-0016
    Country
    JP
    Correspondent
    Satoru Ikeda

    US Agent

    Business Name
    NSK America Corporation
    Contact Name
    Sean Kaufman
    Address
    Office, 1800 Global Parkway Hoffman Estates
    City
    Hoffman Est
    State
    IL
    ZIP
    60192
    Country
    US
    Email
    [email protected]
    Phone
    888 6751675

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC

    Proprietary Names

    VA370LUXNA VA370ADNA VA370LUXADNA VA370NA VA370 Lux VA370

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)