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

    Axelgaard Manufacturing Co., Ltd.

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer·91 Devices

    Filial af Exhalation Technology ltd, England

    Authorized representative
    🇩🇰 Denmark

    SigmaTech Nordic ApS

    Authorized representative
    🇩🇰 Denmark·5 Manufacturers·311 Devices

    RFX+Care International A/S

    Authorized representative
    🇩🇰 Denmark·2 Manufacturers·646 Devices

    Bureau Medica Intercert DK

    Authorized representative
    🇩🇰 Denmark·2 Manufacturers

    Agilent Technologies Denmark ApS

    Authorized representative
    🇩🇰 Denmark·3 Manufacturers·176 Devices

    Oticon A/S

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer·8 Devices

    EVNIA-AR

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer·1 Device

    V. GULDMANN A/S

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer

    CorporateHealth International ApS

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer

    Louis Nielsen A/S

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer

    TSI Quality Services

    Authorized representative
    🇩🇰 Denmark·34 Manufacturers·381 Devices

    Ferring Pharmaceuticals A/S

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer

    Friendship Europe ApS

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer·557 Devices

    NUNC A/S

    Authorized representative
    🇩🇰 Denmark·2 Manufacturers

    Leisner ApS

    Authorized representative
    🇩🇰 Denmark·1 Manufacturer

    FL Medical ApS

    Authorized representative
    🇩🇰 Denmark·4 Manufacturers

    Footmark Medical ApS

    Importer
    🇩🇰 Denmark·6 Manufacturers

    Testdig ApS

    Importer
    🇩🇰 Denmark·7 Manufacturers