BEUDAMED
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    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

    Ferring Pharmaceuticals A/S

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer

    TSI Quality Services

    Authorized representative
    🇩🇰 Denmark·34 Manufacturers·381 Devices

    Triolab AS

    Importer
    🇩🇰 Denmark·11 Manufacturers