BEUDAMED
    FDA Registration Active 🇨🇳 China

    TENS Electrodes

    Reg #: 3008197884 · FEI: 3008197884 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    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
    K092546

    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

    TENS Electrodes PGF Electrodes IF Electrodes EMS Electrodes

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device