BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    PD-100

    Device
    EU IVDR · Eu Ivd Class A ·PRO Devices A/S·On the market·3 countries

    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

    FDA Enforcement
    Class II ·Terminated·Widex A/S·October 17, 2018

    PD

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·PRO Devices A/S·1 device

    Triolab AS

    Importer
    🇩🇰 Denmark·11 Manufacturers

    MEDIQ DANMARK A/S

    Importer
    🇩🇰 Denmark·14 Manufacturers

    GM Medical A/S

    Importer
    🇩🇰 Denmark·15 Manufacturers

    Abena A/S

    Importer
    🇩🇰 Denmark·20 Manufacturers