BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TIANLE

    DI: 06937572803965 · Model: TF-953G · Zhongshan Tianle Hearing Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TIANLE
    Primary DI
    06937572803965
    Version / Model
    TF-953G
    Company Name
    Zhongshan Tianle Hearing Technology Co., Ltd.
    Labeler DUNS
    546790267
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-02
    Public Version
    1
    Public Version Date
    2025-04-10
    Public Version Status
    New
    Public Device Record Key
    b22e83c0-b344-409e-a353-3d556a6ab4c7

    Device Description

    In The Ear Hearing Aid

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

    GMDN Terms

    Code Name
    34672 Air-conduction hearing aid, in-the-ear

    Identifiers

    Type ID
    Primary 06937572803965