BEUDAMED
    FDA Registration Active 🇨🇳 China

    BEIJING IKEY MEDICAL DEVICE TECHNOLOGY CO., LTD.

    Reg #: 3040391045 · FEI: 3040391045 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    BEIJING IKEY MEDICAL DEVICE TECHNOLOGY CO., LTD.
    Registration Number
    3040391045
    FEI Number
    3040391045
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Floor 1-2, Building 1, 30 Yongchang South Road Beijing, CN 100176
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230120

    Owner / Operator

    Firm Name
    Beijing iKey Medical Device Technology Co., Ltd.
    Operator Number
    10093962
    Address
    Building 1, 30 Yongchang South Road Beijing, CN 100176
    City
    Beijing
    State
    CN-BJ
    Postal Code
    100176
    Country
    CN
    Correspondent
    Lijuan Li

    US Agent

    Business Name
    JOYSUN USA LLC
    Contact Name
    Weian Huang
    Address
    7 Yale Ct
    City
    Coto De Caza
    State
    CA
    ZIP
    92679
    Country
    US
    Email
    [email protected]
    Phone
    949 4624543

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    iKey Total Knee System KeYi Total Knee System

    Establishment Types

    Manufacture Medical Device