Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034880867

FEI Number

3034880867

Entity Name

Natus Sensory Ireland Ltd

City/State/Country

Gort Galway, IE

Establishment Address

IDA Business Park, Gort Galway H91PD92, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Natus Medical Denmark ApS (Owner Number: 10093195)

Owner / Operator Contact Address

2630 TAASTRUP, Hoerskaetten 9, Copenhagen, DK-NOTA 2630, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alpha starter kit Small tip kit Madsen Accuscreen/Alpha Type 1077 - MADSEN Alpha OAE Type 1077 - MADSEN Aipha OAE+ 8-04-16210, 1085 ICS Impulse Monocular Video Frenzel (US only) ICS impulse face cushion kit 8-04-15602, 1085 ICS Impulse (Full w/o webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video) ICS Impulse Strap assembly 8-04-15601, 1085 ICS Impulse (Full w/webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video) Goggle face cushion kit 8-04-16212, 1085 ICS Impulse, Mono. Ocu. Ltd., Lateral Head Impulse, LARP/RALP HeadImpulse, Torsional 8-04-15600, 1085 ICS Impulse (Lateral only Head Impulse System) Vision denied solution kit 8-04-16200, 1085 ICS Impulse Monocular Video Frenzel Insert Earphones Zoomax Luna 8 Zoomax Luna 6 Zoomax Snow 12 Zoomax Snow Eye Zoomax Luna S Zoomax Snow Pad Zoomax Luna Eye Zoomax Acesight VR Zoomax Luna HD 24 Pro FreeFit REM Probe REM Tubes, Blue handle OTOair 2 Bluetooth Dongle OTOair Bluetooth Dongle PMM RECD Probe BIN Long Type 1053 - FreeFit RECD Eartip Kit PMM RECD Probe long Type 1053 - AVS RECD Fitting Kit Probe Tube Holder mk2 1053 Aurical FreeFit PMM RECD Probe Short ICS Impulsa ICS Impulse 1096 Quick Check Probe Gen 2 kit 1096 Probe Diagnostic MADSEN Zodiac MADSEN Zodiac SA Quick Check W/O Printer MADSEN Zodiac SA Clinical W/Printer Madsen Zodiac SA Diagnostic w/printer MADSEN Zodiac SA Diagnostic W/O Printer MADSEN Zodiac PC Quick Check MADSEN Zodiac SA Quick Check w/printer MADSEN Zodiac SA Clinical W/O Printer Zodiac Insert Phone 1096 Diagnostic Probe Gen 2 kit Probe tips Contra TDH39 MADSEN Zodiac PC Clinical 1096 probe, Quick Check MADSEN Zodiac PC Diagnostic Type 1077 MADSEN AccuScreen ABR/TE Type 1077 MADSEN AccuScreen ABR/TE/DP Eartip 4.5 mm pastel pink Acoustic filters Electrodes, snap, disposables Eartip 4.5 mm red brown Eartip yellow 4-7 mm tree Eartip 3.7 mm pastel yellow Eartip 4 mm dark blue Eartip 5 mm pastel blue Acccuscreen starter kit Eartip 4 mm pastel green Type 1077 MADSEN AccuScreen ABR Type 1077 MADSEN AccuScreen TE Otometrics Ear couplers, disposables Type 1077 MADSEN AccuScreen DP Earhugs, disposables Type 1077 MADSEN AccuScreen TE/DP Accuscreen Eartip 4-7 mm tree transparent Type 1077 MADSEN AccuScreen ABR/DP Foamtip 6-10 mm yellow foam Type 1053 - AVS Coupler microphone PMM RECD Probe BIN Short OTOair Bluetooth Dongle REM Tubes, Blue handle PMM RECD Probe long 8-04-15101, 1082 AURICAL HIT PMM RECD Probe BIN Long RECD Eartip Kit RECD Fitting Kit Type 1053 - FreeFit Aurical Hit FreeFit REM Probe PMM RECD Probe Short Probe Tube Holder mk2 OTOair 2 Bluetooth Dongle Reference microphone Audiometer Type 1066 - Astera 2 Insert earphone, mono Type 1081 - Aurical Aud with built in HI-PRO 2 Patient signal, grey Type 1081 - A450 A450, Aurical AUD, Astera 2 Accessory ad on kit incl. 8-72-140 Type 1081 - Aurical Aud Type 1004 - Itera II Patient signal, Blue BC2 Bone Conductor Headset TDH 39 with HB-7 headband REM Tubes Stereo Microphone Type 1066 - Astera Type 1067 - Xeta 1081, Loudspeaker Headset HDA-300 Patient signal, red Headset ME 70 Insert earphone 10 Ohm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-04-23
GWN	Nystagmograph	Neurology	Class 2	882.1460	2025-04-23
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2025-04-23
HPG	Aid, Vision, Electronic, Battery-Powered	Ophthalmic	Class 1	886.5900	2018-12-10
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2025-04-23
GWN	Nystagmograph	Neurology	Class 2	882.1460	2025-04-23
LXV	Apparatus, Vestibular Analysis	Unknown	Class U	N/A	2025-04-23
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2025-04-23
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-04-23
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2025-04-23
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2025-04-13
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2025-04-23

Official Correspondent

Martha Kennedy

US Agent Details

Danda Zhao Business: Danda Zhao Email: danda.zhao@natus.com Phone: (224) 4254814

Related Public Records

Same Entity

Natus Medical Denmark ApS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9612197	Natus Medical Denmark ApS	TAASTRUP Hovedstaden, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010059	Western Systems Research, Inc.	ENGPLUS	2001-02-27
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23
K833045	American Electromedics Corp.	CLINICAL TYMPANOMETER	1983-12-08

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8030229	NIHON KOHDEN TOMIOKA PRODUCTION CENTER	TOMIOKA-SHI Gunma, JP
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034880867. Last updated year: 2026. Please use registration number 3034880867 when referencing this establishment in official correspondence.