Natus Manufacturing Limited

FDA Device Registration & Listing · GORT, Co. Galway, IE · Registration 3005581270

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005581270
FEI Number
3005581270
Entity Name
Natus Manufacturing Limited
City/State/Country
GORT, Co. Galway, IE
Establishment Address
IDA BUSINESS PARK, GORT, Co. Galway --, IE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Natus Medical Incorporated (Owner Number: 9004873)
Owner / Operator Contact Address
3150 Pleasant View Road, Middleton, WI 53562, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K043132
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2013-06-07
JXE Device, Nerve Conduction Velocity Measurement Neurology Class 2 882.1550 2013-06-07
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2013-06-07
GXP Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2013-06-07
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2013-06-07
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2013-06-07
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2013-06-07
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2012-12-12
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2020-01-08
GWN Nystagmograph Neurology Class 2 882.1460 2019-11-08
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2019-12-06
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2012-12-13
ETW Calibrator, Hearing Aid / Earphone And Analysis Systems Ear, Nose, Throat Class 2 874.3310 2019-04-30
GXZ Electrode, Needle Neurology Class 2 882.1350 2014-02-27
ETW Calibrator, Hearing Aid / Earphone And Analysis Systems Ear, Nose, Throat Class 2 874.3310 2019-04-30
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2016-06-06
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2016-06-06
GZL Electrode, Depth Neurology Class 2 882.1330 2015-01-15
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2012-12-13
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2012-12-12
GWL Amplifier, Physiological Signal Neurology Class 2 882.1835 2012-12-12
GWN Nystagmograph Neurology Class 2 882.1460 2025-02-18
GXZ Electrode, Needle Neurology Class 2 882.1350 2012-12-13
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2012-12-13
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2024-09-05
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2012-12-13
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2019-04-30
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2012-12-12
GXZ Electrode, Needle Neurology Class 2 882.1350 2012-12-12
KHH Stimulator, Caloric-Air Ear, Nose, Throat Class 1 874.1800 2019-04-30
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2015-01-19
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2019-04-30
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2025-01-24
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2025-01-24
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-24
GZP Stimulator, Mechanical, Evoked Response Neurology Class 2 882.1880 2025-01-24
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-24
JXE Device, Nerve Conduction Velocity Measurement Neurology Class 2 882.1550 2025-01-24
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2025-01-24
ETY Tester, Auditory Impedance Ear, Nose, Throat Class 2 874.1090 2019-04-30
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2012-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Courtney Walton Business: Natus Email: Courtney.Walton@Natus.com Phone: (651) 4215870

Related Public Records

Same Entity

Natus Medical Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612330 NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) OAKVILLE Ontario, CA
2023988 Natus Medical Incorporated SAN DIEGO, CA, US
3010611950 Natus Neurology Incorporated Middleton, WI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033010 Brainz Instruments , Ltd. BRM2 BRAIN MONITOR 2003-10-10
K991012 Siemens Medical Solutions USA, Inc. SIEMENS INFINITY EEG POD 1999-06-24
K852587 Tracor Northern, Inc. CDSA(COLOR DENSITY, SPECTRAL ARRRAY) 1985-08-16
K880088 Cadwell Laboratories, Inc. CADWELL EXCEL 1988-05-04
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2022 NOX MEDICAL Keldnaholt Reykjavik Iceland 2
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005581270. Last updated year: 2026. Please use registration number 3005581270 when referencing this establishment in official correspondence.
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