BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Geniant Cranial (Navigated Neurosurgical Positioning Robot)

    Reg #: 3027375826 · FEI: 3027375826 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KOH YOUNG TECHNOLOGY INC.
    Registration Number
    3027375826
    FEI Number
    3027375826
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F, 66-27, Gwangdae 2-gil, Sejongdaewang-myeon
    City
    Yeoju Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K241333

    Owner / Operator

    Firm Name
    KOH YOUNG TECHNOLOGY INC.
    Operator Number
    10092592
    Address
    1F, 66-27, Gwangdae 2-gil, Sejongdaewang-myeon
    City
    Yeoju
    State
    Gyeonggi
    Postal Code
    12647
    Country
    KR

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    Geniant Cranial (Navigated Neurosurgical Positioning Robot)

    Establishment Types

    Manufacture Medical Device