BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BLUECORE COMPANY Co., Ltd.

    Reg #: 3014144061 · FEI: 3014144061 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BLUECORE COMPANY Co., Ltd.
    Registration Number
    3014144061
    FEI Number
    3014144061
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #402-404, 34, Yari 3-gil, Mulgeum-eup
    City
    Yangsan Gyeongnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230268

    Owner / Operator

    Firm Name
    BLUECORE COMPANY Co., Ltd.
    Operator Number
    10056208
    Address
    605#, 34, Yari 3-gil, Mulgeum-eup
    City
    Yangsan-si
    State
    Gyeongnam
    Postal Code
    50652
    Country
    KR
    Correspondent
    Da Eun Park

    US Agent

    Business Name
    Bio-Med USA Inc
    Contact Name
    Young Chi
    Address
    27 New England Drive
    City
    Ramsey
    State
    NJ
    ZIP
    07446
    Country
    US
    Email
    [email protected]
    Phone
    973 2785222

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    ZenPro 40 PICORE IRIS Trinity IRIS Pi Nd YAG Laser

    Establishment Types

    Manufacture Medical Device