BEUDAMED
    Eu Mdr Eu Md Class 2a On The Market ๐Ÿ‡บ๐Ÿ‡ธ United States

    HEARING AIDS - OTHER

    Apple Inc. ยท ๐Ÿ‡บ๐Ÿ‡ธ United States
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    0
    Countries
    18
    Notified Bodies
    0

    Basic Information

    Primary DI
    00195949149931
    Basic UDI-DI Code
    0195949HAFCR
    Reference
    Hearing Aid Feature 1.X
    Device Types
    None provided
    Regulation
    Eu Mdr
    Classification
    Eu Md Class 2a
    Status
    On The Market
    Manufacturer
    Apple Inc.

    Additional Description

    The Hearing Aid Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Hearing Aid Feature utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing professional. The device is intended for Over-the- Counter use.

    CND Nomenclature Codes

    Code Description
    Y214599 HEARING AIDS - OTHER

    Available In Countries

    ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia

    Similar Devices

    Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).

    Sterivap HP

    Device
    EU MDR · Eu Md Class 2a ·BMT Medical Technology s.r.o.·On the market·11 countries

    Plurasil Situform, Refill

    Device
    EU MDR · Eu Md Class 2a ·4dentPro GmbH & Co. KG·On the market·9 countries

    OTOPLAN

    Device
    EU MDR · Eu Md Class 2a ·CASCINATION AG·On the market·31 countries

    3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON

    Device
    EU MDR · Eu Md Class 2a ·TOPCON CORPORATION·On the market·2 countries

    Monoartยฎ Adattatore per Aspirasaliva Adapter for Saliva Ejector Adapter fรผr Speichelsauger

    Device
    EU MDR · Eu Md Class 2a ·EURONDA S.P.A.·On the market·30 countries

    Monoartยฎ Adattatore per Aspirasaliva Adapter for Saliva Ejector Adapter fรผr Speichelsauger

    Device
    EU MDR · Eu Md Class 2a ·EURONDA S.P.A.·On the market·30 countries
    View all