BEUDAMED
    FDA Registration Active 🇫🇷 France

    ITSA Medical

    Reg #: 3032579106 · FEI: 3032579106 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    ITSA Medical
    Registration Number
    3032579106
    FEI Number
    3032579106
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2720 Chemin St Bernard
    City
    Vallauris Alpes-Maritimes
    Country
    FR

    Owner / Operator

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

    US Agent

    Business Name
    OTICON MEDICAL LLC
    Contact Name
    Laura Dixon
    Address
    580 Howard Ave
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    760 9082393 ext. 181

    Products

    Device Name Product Code
    Active Implantable Bone Conduction Hearing System PFO

    Proprietary Names

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

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)