BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    NU EYNE CO., LTD.

    Reg #: 3015946733 · FEI: 3015946733 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NU EYNE CO., LTD.
    Registration Number
    3015946733
    FEI Number
    3015946733
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #608, 28, Digital-ro 30-gil
    City
    Guro-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K242719

    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
    Jung Ryun Ahn
    Address
    115 East 34th street, 13J
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US
    Email
    [email protected]
    Phone
    646 3576058

    Products

    Device Name Product Code
    Stimulator, Nerve, Electrical, Transcutaneous, For Migraine PCC
    Transcutaneous Nerve Stimulator For Adhd QGL

    Proprietary Names

    ELEXIR 2 (Model: ALLIVE3) ELEXIR Electrode (Model: PS-2HP2) ADDNOX Electrode (Model: PS-2HP2) ADDNOX (Model: BPSPM1) Smile Allive (Model: AL-2HP) Allive (Model: ALLIVE01) ELEXIR (Model: ALLIVE2) ELEXIR (Model: AL-2HP2)

    Establishment Types

    Manufacture Medical Device