BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HUMANSCAN CO., LTD

    Reg #: 3016076141 · FEI: 3016076141 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    HUMANSCAN CO., LTD
    Registration Number
    3016076141
    FEI Number
    3016076141
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15, Emtibeuibuk-ro 137beon-gil
    City
    Siheung-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200158

    Owner / Operator

    Firm Name
    HUMANSCAN CO., LTD
    Operator Number
    10026862
    Address
    15, Emtibeuibuk-Ro 137beon-Gil
    City
    Siheung-Si
    State
    Gyeonggi
    Postal Code
    15119
    Country
    KR
    Correspondent
    Won Soup Park

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Biopsy Needle Guide Kit OIJ
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    L6-24-D Probe CW8 L10-5v transducer L10-5v C5-2v P8D L3-9i-RS Ultrasound Transducer 18H5 Model 11284924 S1-5-D 3Sp-D M5S-D L10-5v TC-ZIF 18H5 S1-4-D C2-7VN-D, M5S-D, S1-5-D, C2-7-D, L3-9i-D IC4-10-D Probe 7L2 L10-5v(TC-ZIF type) 5Sp 3Sp

    Establishment Types

    Manufacture Medical Device