BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OnDemand3DTM

    Reg #: 3010445368 · FEI: 3010445368 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RAY CO., LTD,
    Registration Number
    3010445368
    FEI Number
    3010445368
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F~3F, 4F(Part), 5F, 265, Daeji-ro
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K070464

    Owner / Operator

    Firm Name
    Ray Co., Ltd,
    Operator Number
    10045096
    Address
    1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    16882
    Country
    KR
    Correspondent
    Minkab Choi

    US Agent

    Business Name
    RAY AMERICA INC
    Contact Name
    JANGTAE (BRANDON) YOO
    Address
    400 Kelby Street, Ste 1500
    City
    Fort Lee
    State
    NJ
    ZIP
    07024
    Country
    US
    Email
    [email protected]
    Phone
    201 7450200

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    OnDemand3DTM

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device