BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Affinity 2

    Reg #: 9710051 · FEI: 3000254565 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INTERACOUSTICS A/S
    Registration Number
    9710051
    FEI Number
    3000254565
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Audiometer Alle 1
    City
    Middelfart Syddanmark
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K043219

    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
    Grason-Stadler
    Contact Name
    Brandon Bell
    Address
    10395 West 70th Street
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    952 9476097

    Products

    Device Name Product Code
    Audiometer EWO
    Calibrator, Hearing Aid / Earphone And Analysis Systems ETW

    Proprietary Names

    Affinity 2 Affinity Compact Callisto Equinox Affinity Sanibel REM Probe Tubes, type A Sanibel REM Probe Tubes, type C Type B probe tube Sanibel REM Probe Tubes, type D Probe tubes, type A HIT 440 Module AC 440 Module

    Establishment Types

    Manufacture Medical Device