BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GEMSS HEALTHCARE CO., LTD.

    Reg #: 3030089787 · FEI: 3030089787 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GEMSS HEALTHCARE CO., LTD.
    Registration Number
    3030089787
    FEI Number
    3030089787
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si
    City
    Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K133695

    Owner / Operator

    Firm Name
    GEMSS HEALTHCARE CO., LTD.
    Operator Number
    10089429
    Address
    1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si
    City
    Gyeonggi
    State
    KR-41
    Postal Code
    10952
    Country
    KR
    Correspondent
    Jiho Park

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St Ste 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB

    Proprietary Names

    TITAN 11 Spinel 3G HORIZON XVISION-525 HI-500 SATURN-F PF32 SATURN-F PF40 HI-300 SATURN-F PF50 KMC-650P KMC-650 XPLUS 35FD XPLUS 35 Series XPLUS 35 SPINEL 12HD

    Establishment Types

    Manufacture Medical Device