BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ELEHEAR

    DI: 06977352080124 · Model: RIC 03 · ELEHEAR Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ELEHEAR
    Primary DI
    06977352080124
    Version / Model
    RIC 03
    Company Name
    ELEHEAR Inc.
    Labeler DUNS
    699441039
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-12
    Public Version
    2
    Public Version Date
    2025-03-03
    Public Version Status
    Update
    Public Device Record Key
    32be4708-52df-4e7a-9e60-7160df343211
    Distribution End Date
    2025-03-03

    Device Description

    Hearing aids, Champagne Gold

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    47169 Air-conduction hearing aid, receiver-in-canal

    Identifiers

    Type ID
    Primary 06977352080124