BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ASADAL-M1

    Reg #: 3029915542 · FEI: 3029915542 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HUONS MEDITECH CO., LTD
    Registration Number
    3029915542
    FEI Number
    3029915542
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #216~219, 314, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K131721

    Owner / Operator

    Firm Name
    Huons USA
    Operator Number
    10088996
    Address
    200 Spectrum Center Drive, Ste 4036
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    US Agent

    Business Name
    Edward
    Contact Name
    Taehyung Kim
    Address
    200 Spectrum Center Drive, Suite 4036, Irvine, CA 92618
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 4910649

    Products

    Device Name Product Code
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS

    Proprietary Names

    ASADAL-M1

    Establishment Types

    Manufacture Medical Device