BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HERA Z20e

    Reg #: 8041160 · FEI: 3010289997 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SAMSUNG MEDISON CO., LTD.
    Registration Number
    8041160
    FEI Number
    3010289997
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3366, Hanseo-ro, Nam-myeon
    City
    HONGCHEON-GUN Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K241971

    Owner / Operator

    Firm Name
    SAMSUNG MEDISON CO., LTD.
    Operator Number
    8041160
    Address
    3366, Hanseo-ro, Nam-myeon,
    City
    Hongcheon-gun
    State
    Gangwon
    Postal Code
    25108
    Country
    KR
    Correspondent
    Lisa Jang

    US Agent

    Business Name
    NEUROLOGICA CORPORATION
    Contact Name
    Ninad Gujar
    Address
    14 Electronics Ave
    City
    Danvers
    State
    MA
    ZIP
    01923
    Country
    US
    Email
    [email protected]
    Phone
    978 5648632

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    HERA Z20e Z20 R20 R30 HERA Z20 HERA Z30 HERA Z20s

    Establishment Types

    Manufacture Medical Device