BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ADDNOX (Model: BPSPM1)

    Reg #: 3015946733 · FEI: 3015946733 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NU EYNE CO., LTD.
    Registration Number
    3015946733
    FEI Number
    3015946733
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #608, 28, Digital-ro 30-gil
    City
    Guro-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K243289

    Owner / Operator

    Firm Name
    Nu Eyne Co., Ltd.
    Operator Number
    10078817
    Address
    #608, 28, Digital-ro 30-gil
    City
    Guro-gu
    State
    Seoul
    Postal Code
    08389
    Country
    KR
    Correspondent
    Dohyoung Kim

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    SEOK WOO KIM
    Address
    5450 ASTOR LANE #203
    City
    Rolling Mdws
    State
    IL
    ZIP
    60008
    Country
    US
    Email
    [email protected]
    Phone
    847 9241545

    Products

    Device Name Product Code
    Transcutaneous Nerve Stimulator For Adhd QGL

    Proprietary Names

    ADDNOX (Model: BPSPM1) ADDNOX Electrode (Model: PS-2HP2)

    Establishment Types

    Manufacture Medical Device