BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eargo SE

    DI: 00850010429748 · Model: 99-0189-001 · Eargo, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eargo SE
    Primary DI
    00850010429748
    Version / Model
    99-0189-001
    Company Name
    Eargo, Inc.
    Labeler DUNS
    079865289
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-03
    Public Version
    1
    Public Version Date
    2025-04-11
    Public Version Status
    New
    Public Device Record Key
    12a691b6-1244-44e3-8eb3-4db28e08abc3

    Device Description

    Eargo SE Plus Bundle

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00850010429748

    Premarket Submissions

    Submission Number Supplement Number
    K221698 000