BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tympa Otoscope System

    DI: 15060753520004 · Model: iPhone XR · TYMPA HEALTH TECHNOLOGIES LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Tympa Otoscope System
    Primary DI
    15060753520004
    Version / Model
    iPhone XR
    Company Name
    TYMPA HEALTH TECHNOLOGIES LIMITED
    Labeler DUNS
    223449035
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-04
    Public Version
    1
    Public Version Date
    2025-02-12
    Public Version Status
    New
    Public Device Record Key
    a244816d-c4c7-41d8-93e5-6a9d14a9d2ca

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    ERA Otoscope
    EWO Audiometer

    GMDN Terms

    Code Name
    65129 Video otoscope/audiometer

    Identifiers

    Type ID
    Primary 15060753520004