BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    18H5

    Reg #: 3016076141 · FEI: 3016076141 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    HUMANSCAN CO., LTD
    Registration Number
    3016076141
    FEI Number
    3016076141
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15, Emtibeuibuk-ro 137beon-gil
    City
    Siheung-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K213487

    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
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

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

    Proprietary Names

    18H5 L10-5v TC-ZIF

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)