BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HEURON CO., LTD.

    Reg #: 3016727312 · FEI: 3016727312 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HEURON CO., LTD.
    Registration Number
    3016727312
    FEI Number
    3016727312
    Status
    Active
    Expiry Year
    2026
    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
    Yuri Choi

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS
    System, Image Processing, Radiological LLZ
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Heuron ICH Veuron-Brain-mN1 Veuron-Brain-pAb2 Veuron-Brain-pAb

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)