BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Ear tip, ER10C-03

    Reg #: 9710051 · FEI: 3000254565 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    2
    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
    K930553

    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

    Proprietary Names

    Ear tip, ER10C-03 Foam ear tip, 10 mm, ER10C Foam ear tip, 10 mm, ER1/ER2 Foam ear tip, 13 mm, ER10B+ Foam ear tip, 13 mm, ER10C Foam ear tip, 18 mm, ER10C ER-2 Insert Earphones Foam ear tip, 13 mm, ER1/ER2 Ear tip, ER10C-06 Ear tip, ER10C-05 Ear tip, ER10C-04

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility