BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Heuron ICH

    Reg #: 3016727312 · FEI: 3016727312 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HEURON CO., LTD.
    Registration Number
    3016727312
    FEI Number
    3016727312
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10F, C, 150, Yeongdeungpo-ro, Yeongdeungpo-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K233247

    Owner / Operator

    Firm Name
    Heuron Co., Ltd.
    Operator Number
    10080283
    Address
    10F, C, 150, Yeongdeungpo-ro, Yeongdeungpo-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    07292
    Country
    KR
    Correspondent
    Eunsol Vicky Lee

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    SEOK WOO KIM
    Address
    5450 ASTOR LANE #203
    City
    Rolling Mdws
    State
    IL
    ZIP
    60008
    Country
    US
    Email
    [email protected]
    Phone
    847 9241545

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS

    Proprietary Names

    Heuron ICH

    Establishment Types

    Manufacture Medical Device