BEUDAMED
    FDA Registration Active 🇨🇳 China

    Adhesive Electrodes

    Reg #: 3008197884 · FEI: 3008197884 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GMDASZ MANUFACTURING CO., LTD.
    Registration Number
    3008197884
    FEI Number
    3008197884
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room E1308, Xihaimingzhu Building, Taoyuan Road , Nanshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160138

    Owner / Operator

    Firm Name
    GMDASZ Manufacturing Co., Ltd.
    Operator Number
    10031210
    Address
    Building #1, HMB 3rd Industrial Zone, Baoan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518126
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY

    Proprietary Names

    Adhesive Electrodes

    Establishment Types

    Manufacture Medical Device