BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Prodigy

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

    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
    K161682

    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
    Densitometer, Bone KGI

    Proprietary Names

    Prodigy

    Establishment Types

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