BEUDAMED
    3 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Denmark ×

    LiNA Medical ApS

    Manufacturer
    🇩🇰 Denmark·TUV NORD Polska Sp. z o.o

    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

    TNP/MDR/0013/5613/2023

    Certificate
    MDR QMS·LiNA Medical ApS·TUV NORD Polska Sp. z o.o