BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OSCAR Prime

    Reg #: 3005843418 · FEI: 3005843418 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GENORAY CO., LTD.
    Registration Number
    3005843418
    FEI Number
    3005843418
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    60, Dunchon-daero 541beon-gil, Jungwon-gu
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K181943

    Owner / Operator

    Firm Name
    GENORAY CO., LTD.
    Operator Number
    9093488
    Address
    60, Dunchon-daero 541beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi, 13212, KOREA, SOUTH
    City
    SEONGNAM
    State
    KR-NOTA
    Postal Code
    13212
    Country
    KR

    US Agent

    Business Name
    GENORAY America Inc.
    Contact Name
    Anna Park
    Address
    1220 N Simon Cir, Suite B
    City
    Anaheim
    State
    CA
    ZIP
    92806
    Country
    US
    Email
    [email protected]
    Phone
    855 4366729 ext. 236

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    OSCAR Prime OSCAR Classic

    Establishment Types

    Manufacture Medical Device