BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OEC 9800

    Reg #: 3008632256 · FEI: 3008632256 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LJ BUSINESS CORPORATION
    Registration Number
    3008632256
    FEI Number
    3008632256
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F, 2 Chome 2-1, Nihonbashikakigara-Cho
    City
    Chuo Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K111551

    Owner / Operator

    Firm Name
    LJ Business Corporation
    Operator Number
    10048369
    Address
    4F Tomida Building, 2-2-1 Nihonbashi-kakigaracho
    City
    Chuo-ku
    State
    Tokyo
    Postal Code
    103-0014
    Country
    JP
    Correspondent
    Lijun Huang

    US Agent

    Business Name
    Red Medical Solutions, Inc.
    Contact Name
    Yolanda Pena
    Address
    427 W Main St Ste 8
    City
    Blue Point
    State
    NY
    ZIP
    11772
    Country
    US
    Email
    [email protected]
    Phone
    480 9293550 ext. 979

    Products

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

    Proprietary Names

    OEC 9800

    Establishment Types

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