BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Celebrate family (Sonic)

    Reg #: 3009307953 · FEI: 3009307953 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    52
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Demant Operations Poland Sp. z o.o.
    Registration Number
    3009307953
    FEI Number
    3009307953
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ul. Lubieszynska 59
    City
    Mierzyn Zachodniopomorskie
    Country
    PL

    Owner / Operator

    Firm Name
    DEMANT A/S
    Operator Number
    8010048
    Address
    KONGEBAKKEN 9, --
    City
    SMORUM
    State
    DK-NOTA
    Postal Code
    DK-2765
    Country
    DK
    Correspondent
    Veronique Schou

    US Agent

    Business Name
    Oticon Inc.
    Contact Name
    Love Aggarwal
    Address
    580 Howard Ave
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    732 8534740

    Products

    Device Name Product Code
    Face Plate Hearing Aid LRB

    Proprietary Names

    Celebrate family (Sonic) Nera Pro (Oticon) MOVE (Bernafon) Zerena 5 (Bernafon) Zerena 3 (Bernafon) Pep™ family (Sonic) Agil Pro (Oticon) Acto Pro (Oticon) Prio (Bernafon) Nera (Oticon) Zerena 7 (Bernafon) Alta Pro (Oticon) SAPHIRA 5 (Bernafon) Opn3 (Oticon) lno (Oticon) Ria Pro (Oticon) SoundLink 2 App family (Sonic) JUNA 7 (Bernafon) Alta (Oticon) JUNA 9 (Bernafon) Philips Hear-Link App (SBO Hearing) HearLink000 (SBO Hearing) Agil (Oticon) NEVARA 1 (Bernafon) Neo (Bernafon) Nera2 Pro (Oticon) Get (Oticon) CARISTA 5 (Bernafon) Enchant ™ family (Sonic) Inizia 3 (Bernafon) Alta2 Pro (Oticon) HEARTOO1 (Bernafon) Inizia 1 (Bernafon) Ria2 (Oticon) Opn 1 (Oticon) Zerena 1 (Bernafon) SAPHIRA 3 (Bernafon) CHRONOS 5 (Bernafon) Opn 2 (Oticon) Remote Control (Bernafon) Zerena 9 (Bernafon) ACRIVA 7 (Bernafon) Nera2 (Oticon) CARISTA 3 (Bernafon) Alta2 (Oticon) ACRIVA 9 (Bernafon) Ria2 Pro (Oticon) Oticon Own (SBO Hearing) Sonic Radiant (SBO Hearing) Philips HearLink 30 (SBO Hearing) Cheer ™ family (Sonic) Charm family (Sonic)

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device