BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Natus Manufacturing Limited

    Reg #: 3005581270 · FEI: 3005581270 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    130
    Establishment Types
    5
    Classifications
    27

    Registration Details

    Registration Name
    Natus Manufacturing Limited
    Registration Number
    3005581270
    FEI Number
    3005581270
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    IDA BUSINESS PARK
    City
    GORT, Co. Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K874735

    Owner / Operator

    Firm Name
    Natus Medical Incorporated
    Operator Number
    9004873
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US

    US Agent

    Business Name
    Natus
    Contact Name
    Courtney Walton
    Address
    3610 County Road 101 S
    City
    Wayzata
    State
    MN
    ZIP
    55391
    Country
    US
    Email
    [email protected]
    Phone
    651 4215870

    Products

    Device Name Product Code
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Device, Nerve Conduction Velocity Measurement JXE
    Stimulator, Photic, Evoked Response GWE
    Methyl Methacrylate For Cranioplasty GXP
    Stimulator, Auditory, Evoked Response GWJ
    Stimulator, Electrical, Evoked Response GWF
    Electromyograph, Diagnostic IKN
    Electrode, Cutaneous GXY
    Electrode, Needle, Diagnostic Electromyograph IKT
    Nystagmograph GWN
    Calibrator, Hearing Aid / Earphone And Analysis Systems ETW
    Electrode, Needle GXZ
    Burst Suppression Detection Software For Electroencephalograph ORT
    Amplitude-Integrated Electroencephalograph OMA
    Electrode, Depth GZL
    Stimulator, Nerve, Battery-Powered BXN
    Amplifier, Physiological Signal GWL
    Otoscope ERA
    Stimulator, Caloric-Air KHH
    Cable, Electrode IKD
    Stimulator, Mechanical, Evoked Response GZP
    Tester, Auditory Impedance ETY
    Ventilatory Effort Recorder MNR
    Audiometer EWO
    Cushion, Earphone (For Audiometric Testing) ETT
    Apparatus, Vestibular Analysis LXV
    Hearing Aid, Air-Conduction, Prescription ESD

    Proprietary Names

    Synergy Focus Natus Synergy Focus UltraPro S100 Stim and Recording Electrode,Electrode Cutaneous Allergan Botox Needle Electrode 8-04-15600, 1085 ICS Impulse (Lateral only Head Impulse System) 8-04-16200, 1085 ICS Impulse Monocular Video Frenzel 8-04-16212, 1085 ICS Impulse, Mono. Ocu. Ltd., Lateral Head Impulse, LARP/RALP HeadImpulse, Torsional 8-04-15601, 1085 ICS Impulse (Full w/webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video) 8-04-16210, 1085 ICS Impulse Monocular Video Frenzel (US only) 8-04-15602, 1085 ICS Impulse (Full w/o webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video) Dantec DCN Disposable Concentric Needle TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES FreeFit REM Probe RECD Fitting Kit PMM RECD Probe BIN Long RECD Eartip Kit PMM RECD Probe BIN Short Type 1053 - FreeFit OTOair 2 Bluetooth Dongle Probe Tube Holder mk2 Type 1053 - AVS PMM RECD Probe Short PMM RECD Probe long REM Tubes, Blue handle OTOair Bluetooth Dongle Subdermal needle electrode Reference microphone Coupler microphone Background Pattern Classification Leadpoint Focus 9031C0881 9031E0752 9033G0703 9033A0811AA 9033A0821AA 9033A0821HA 9031S2305 ELECTRODE/SURFACE TWISTED PAIR Clavis 9015A0012 9015A0011 8015A0012 ICS Dizovery (1091) STERILE EMG ELECTRODES Grass® MR Conditional/CT Cup Electrodes, Single and Array TECA ELITE DISPOSABLE CONCENTRIC NEEDLES Type 1093 - Otoscan Specula, 3mm, normal, 12 Specula, 3mm, cerumen, 12 Type 1076 - OTOcam 300 1093, HEADSET HS3 TECA ELITE DISPOSABLE MONOPOLAR NEEDLES Specula, disposable Type 1079 - ICS Aircal Microelectrode recording cable MER Cable Holder for Dantec™ DCN Disposable Concentric Needle Electrodes Cable Electrodes Eartip 5 mm pastel blue Eartip 4 mm dark blue Foamtip 6-10 mm yellow foam Otometrics Ear couplers, disposables Type 1077 MADSEN AccuScreen DP Earhugs, disposables Eartip 4.5 mm red brown Type 1077 MADSEN AccuScreen TE Eartip 4.5 mm pastel pink Acoustic filters Eartip yellow 4-7 mm tree Electrodes, snap, disposables Acccuscreen starter kit Type 1077 MADSEN AccuScreen TE/DP Type 1077 MADSEN AccuScreen ABR/DP Eartip 4-7 mm tree transparent Type 1077 MADSEN AccuScreen ABR/TE Type 1077 MADSEN AccuScreen ABR Type 1077 MADSEN AccuScreen ABR/TE/DP Eartip 4 mm pastel green Eartip 3.7 mm pastel yellow UltraPro S100 with Integrated Ultrasound MADSEN Zodiac SA Quick Check w/ printer MADSEN Zodiac SA Clinical w/ printer Zodiac insert phone MADSEN Zodiac PC Clinical MADSEN Zodiac SA Diagnostic w/o printer MADSEN Zodiac SA Quick Check w/o printer MADSEN Zodiac PC Diagnostic Contra TDH39 MADSEN Zodiac SA Diagnostic w/ printer MADSEN Zodiac PC Quick Check Probe Tips 1096 Probe, Diagnostic MADSEN Zodiac SA Clinical w/o printer 1096 Diagnostic probe Gen 2 Kit 1096 Quick Check Probe Gen 2 kit 1096 Probe, Quick Check XactTrace Universal XactTrace Belts NICOLET EDX 9013L0362 Handheld Bipolar Stimulator 9013L3522 Replacement Felt Tips for Bipolar Stim 9013S0352 HUSH Bipolar Bar Electr Type 1077 - MADSEN Alpha OAE Type 1077 - MADSEN Aipha OAE+ Alpha starter kit Small tip kit Grass Electrode 9013S0242 Pre-gelled surface electrode 9013L0453 Pre-gelled surface electrode Headset ME 70 Patient signal, Blue B71 Bone Conductor w. Headband Type 1067 - Xeta 1081, Loudspeaker Type 1081 - Aurical Aud with built in HI-PRO 2 Insert earphone, mono Patient signal, grey Type 1004 - Itera II Type 1081 - Aurical Aud Stereo Microphone Type 1081 - A450 Patient signal, red REM Tubes Insert earphone 10 Ohm Headset HDA-300 Accessory ad on kit incl. 8-72-140 Type 1066 - Astera Type 1066 - Astera 2 Headset TDH 39 with HB-7 headband BC2 Bone Conductor Eartips Bo-ject® DHN Disposable Hypodermic Needle Electrode Myoject Luer Lock Needle Electrode Goggle face cushion kit Strap assembly Type 1085 - ICS Impulse Vision denied solution kit ICS impulse face cushion kit Nicolet EDX with Integrated Ultrasound Type Noahlink - Noahlink Type 1072 - HI-PRO 2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device