BEUDAMED
    FDA Registration Active 🇨🇳 China

    Behind-The-Ear Hearing Aid

    Reg #: 3010408889 · FEI: 3010408889 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    XIAMEN RETONE HEARING TECHNOLOGY CO., LTD.
    Registration Number
    3010408889
    FEI Number
    3010408889
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 209, 2nd floor, No. 999 Tianma Road, Jimei District
    City
    Xiamen Fujian
    Country
    CN

    Owner / Operator

    Firm Name
    Xiamen Retone Hearing Technology Co., Ltd.
    Operator Number
    10044151
    Address
    Room 209, 2nd floor, No. 999 Tianma Road, Jimei District
    City
    Xiamen
    State
    Fujian
    Postal Code
    361000
    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
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG

    Proprietary Names

    Behind-The-Ear Hearing Aid In-The-Ear Hearing Aid K1625BE, K1619BE, Smart1604LE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device