BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Geniant Cranial (Navigated Neurosurgical Positioning Robot)

    Reg #: 3027305794 · FEI: 3027305794 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KM HEALTHCARE
    Registration Number
    3027305794
    FEI Number
    3027305794
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    31-51, Geumhak-ro, Donsong-eup,
    City
    Cheorwon-gun, Gangwon-do
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K241333

    Owner / Operator

    Firm Name
    KM Healthcare
    Operator Number
    10087950
    Address
    144, Donggureung-ro 395 beon-gil
    City
    Guri-si, Gyeonggi-do
    State
    KR-NOTA
    Postal Code
    11905
    Country
    KR

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    Geniant Cranial (Navigated Neurosurgical Positioning Robot)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)