BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HANDY-MATE

    Reg #: 9611253 · FEI: 3002807687 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NAKANISHI INC.
    Registration Number
    9611253
    FEI Number
    3002807687
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 SHIMOHINATA
    City
    Kanuma Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K990646

    Owner / Operator

    Firm Name
    NAKANISHI INC.
    Operator Number
    8030216
    Address
    1800 Global Pkwy
    City
    Hoffman Est
    State
    IL
    Postal Code
    60192
    Country
    US
    Correspondent
    Satoru Ikeda

    US Agent

    Business Name
    NSK AMERICA CORPORATION
    Contact Name
    SEAN KAUFMAN
    Address
    1800 Global Pkwy
    City
    Hoffman Est
    State
    IL
    ZIP
    60192
    Country
    US
    Email
    [email protected]
    Phone
    888 6751675

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    HANDY-MATE Viva Mate 3 Viva Mate ViVa 3 S 120V Viva Mate 3U

    Establishment Types

    Manufacture Medical Device