BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Sample bag - AuDX and OAE foam tips

    Reg #: 9710051 · FEI: 3000254565 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    38
    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

    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
    Cushion, Earphone (For Audiometric Testing) ETT

    Proprietary Names

    Sample bag - AuDX and OAE foam tips EARturtle Ear Tip, flanged Sanibel foam tip, large Ear Tip, infant Assortment Box Amplivox SnapPROBE(TM) Accessories Box AuDX Ear Tip Sanibel foam tip sample kit Assortment Box 1161 Sanibel foam tip, medium Assortment Box BET25 Sanibel ADI Ear Tip kit Assortment Box 1171 AOT Ear Tip ADI Ear tip sample kit Infant Ear Tip B Preemie Ear Tip Sanibel foam tip, small MT4 Ear Tip Ear Tip Ear Tip, umbrella Assortment Box BET55 Sanibel Jumbo OAE foam ear tip EarCup Assortment Box 162 Assortment box 1154 ANA Ear Tip Adult OAE foam ear tip Infant Ear Tip A Pediatric OAE foam ear tip OAE Ear Tip Ear Tip, OAE-3 Ear tips 8 - 15 mm mushroom Sanibel ADI Scre. Ear Tip kit Ear Tip, mushroom Ear Tip, OAE-4 Pediatric Eartip Kit

    Establishment Types

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