BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    flysound

    DI: 00850080488140 · Model: H6 · Shenzhen Flysounds Medical Technology Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    flysound
    Primary DI
    00850080488140
    Version / Model
    H6
    Company Name
    Shenzhen Flysounds Medical Technology Co.,Ltd.
    Labeler DUNS
    978407839
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-16
    Public Version
    1
    Public Version Date
    2026-01-26
    Public Version Status
    New
    Public Device Record Key
    cae2cf8b-54c3-40c8-af44-95dddf9b6c65

    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
    34671 Air-conduction hearing aid, behind-the-ear

    Identifiers

    Type ID
    Primary 00850080488140