BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Spare Fixation Screws

    Reg #: 3009307953 · FEI: 3009307953 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    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

    Regulatory Submissions

    510(k) Number
    K240614

    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
    Active Implantable Bone Conduction Hearing System PFO

    Proprietary Names

    Spare Fixation Screws Sentio 1 Mini, STG Genie Medical BAHS 2024.2 Sentio 1 Mini, DBL Sentio Ti Implant Kit Sentio 1 Mini, SIL Sentio Position Marker, non-sterile Sentio 1 Mini, CNB Sentio 1 Mini, CBE Genie Medical BAHS 2023.1 Sentio 1 Mini, TC Screwdriver HexaDrive

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)