BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Type 1077 MADSEN AccuScreen ABR/DP

    Reg #: 9612197 · FEI: 3002807554 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Natus Medical Denmark ApS
    Registration Number
    9612197
    FEI Number
    3002807554
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hoerskaetten 9
    City
    TAASTRUP Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K122067

    Owner / Operator

    Firm Name
    Natus Medical Denmark ApS
    Operator Number
    10093195
    Address
    2630 TAASTRUP, Hoerskaetten 9
    City
    Copenhagen
    State
    DK-NOTA
    Postal Code
    2630
    Country
    DK
    Correspondent
    Martha Kennedy

    US Agent

    Business Name
    Natus Sensory Inc
    Contact Name
    Danda Zhao
    Address
    50 Commerce Drive, Suite 180, Schaumburg
    City
    Schaumburg
    State
    IL
    ZIP
    60173
    Country
    US
    Email
    [email protected]
    Phone
    224 2548140

    Products

    Device Name Product Code
    Stimulator, Auditory, Evoked Response GWJ

    Proprietary Names

    Type 1077 MADSEN AccuScreen ABR/DP Type 1077 MADSEN AccuScreen DP Type 1077 MADSEN AccuScreen ABR/TE Accuscreen Acccuscreen starter kit Eartip 5 mm pastel blue Type 1077 MADSEN AccuScreen TE Earhugs, disposables Type 1077 MADSEN AccuScreen TE/DP Electrodes, snap, disposables Otometrics Ear couplers, disposables Eartip 4 mm dark blue Eartip 3.7 mm pastel yellow Eartip 4 mm pastel green Acoustic filters Eartip 4-7 mm tree transparent Foamtip 6-10 mm yellow foam Type 1077 MADSEN AccuScreen ABR Eartip 4.5 mm red brown Eartip yellow 4-7 mm tree Type 1077 MADSEN AccuScreen ABR/TE/DP Eartip 4.5 mm pastel pink

    Establishment Types

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