BEUDAMED
    FDA Registration Active 🇨🇳 China

    AL-106HD

    Reg #: 3009201600 · FEI: 3009201600 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN GOLDCARE MEDITECH CO., LTD.
    Registration Number
    3009201600
    FEI Number
    3009201600
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    902, Building C, Jinweiyuan Industrial Park, 41 Qingsong Road, Zhukeng Community, Longtian Street, Pingshan District, Shenzhen, China
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K122973

    Owner / Operator

    Firm Name
    Shenzhen GoldCare Meditech Co., Ltd.
    Operator Number
    10045780
    Address
    902, Building C, Jinweiyuan Industrial Park, 41 Qingsong Road, Zhukeng Community, Longtian Street
    City
    Pingshan District, Shenzhen
    State
    Guangdong
    Postal Code
    518118
    Country
    CN
    Correspondent
    Benneng Xu

    US Agent

    Business Name
    Amar Plastics,Inc.
    Contact Name
    Amar Agadi
    Address
    100 West Industrial Road, Addison,IL 60101
    City
    Addison
    State
    IL
    ZIP
    60101
    Country
    US
    Email
    [email protected]
    Phone
    630 9257446

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    AL-106HD AL-106

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)