BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    RHINOSCAN MODEL SRE2000/ SRE2100

    Reg #: 9710051 · FEI: 3000254565 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    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
    K022311

    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
    Rhinoanemometer (Measurement Of Nasal Decongestion) BXQ

    Proprietary Names

    RHINOSCAN MODEL SRE2000/ SRE2100 RHINOSTREAM RHINOMANOMETER MODULE

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device