BEUDAMED
    FDA Registration Active 🇨🇳 China

    Bfix® Orthopedic External Fixator Systems

    Reg #: 3018269629 · FEI: 3018269629 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD.
    Registration Number
    3018269629
    FEI Number
    3018269629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room F201, Floor2, Building 6, No.125, LongPan Road, Malu Town, Jiading District, 201801, Shanghai, China
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K200491

    Owner / Operator

    Firm Name
    Aike (Shanghai) Medical Instrument Co., Ltd.
    Operator Number
    10080234
    Address
    B320, B321, B322, B323, No. 1128, South Huicheng Road, Jiading Industrial District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201801
    Country
    CN
    Correspondent
    Hao Wang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo KEE
    Address
    19 Holly Cove Ln. Dover, Delaware UNITED STATES
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Pin, Fixation, Threaded JDW

    Proprietary Names

    Bfix® Orthopedic External Fixator Systems ZS6 ZS7

    Establishment Types

    Manufacture Medical Device