BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Smith&Nephew

    Reg #: 3012502601 · FEI: 3012502601 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HI MEDICAL CO., LTD.
    Registration Number
    3012502601
    FEI Number
    3012502601
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B-2005, 583, YANGCHEON-RO , GANGSEO-GU,
    City
    SEOUL
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K020715

    Owner / Operator

    Firm Name
    HI MEDICAL CO., LTD.
    Operator Number
    10052106
    Address
    B-2005, 583, YANGCHEON-RO , GANGSEO-GU,
    City
    SEOUL
    State
    KR-11
    Postal Code
    07547
    Country
    KR
    Correspondent
    SEONG IL CHOI

    US Agent

    Business Name
    SKY EAGLE LOGISTICS. INC
    Contact Name
    MYEONGHO HA
    Address
    247 E REDONDO BEACH BLVD, GARDENA, CA, 90248
    City
    Gardena
    State
    CA
    ZIP
    90248
    Country
    US
    Email
    [email protected]
    Phone
    310 3230161

    Products

    Device Name Product Code
    Automated External Defibrillators (Non-Wearable) MKJ

    Proprietary Names

    Smith&Nephew

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device