FDA Registration Active 🇮🇪 Ireland

Natus Sensory Ireland Ltd

Reg #: 3034880867 · FEI: 3034880867 · Expires 2026
Products
9
Proprietary Names
121
Establishment Types
1
Classifications
9

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Registration Details

Registration Name
Natus Sensory Ireland Ltd
Registration Number
3034880867
FEI Number
3034880867
Status
Active
Expiry Year
2026
Initial Importer
No
Address
IDA Business Park
City
Gort Galway
Country
IE

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
Danda Zhao
Contact Name
Danda Zhao
Address
50 Commerce Dr Ste 180
City
Schaumburg
State
IL
ZIP
60173
Country
US
Phone
224 4254814

Products

Device Name Product Code
Stimulator, Auditory, Evoked Response GWJ
Nystagmograph GWN
Audiometer EWO
Aid, Vision, Electronic, Battery-Powered HPG
Calibrator, Hearing Aid / Earphone And Analysis Systems ETW
Apparatus, Vestibular Analysis LXV
Tester, Auditory Impedance ETY
Hearing Aid, Air-Conduction, Prescription ESD
Stimulator, Caloric-Air KHH

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 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 Coupler microphone PMM RECD Probe BIN Short 8-04-15101, 1082 AURICAL HIT Aurical Hit 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 Hi Pro Type 1072 - HI-PRO 2 Type Noahlink - Noahlink Type 1079 - ICS Aircal AirCal Specula, disposable 8-49-92700 Otosuite Vestibular Software 4.4 45652 1091, ICS Dizcovery LCD Panels 47451 1091, ICS Dizcovery Universal Face Cushion (qty 4) ICS Dizcovery 45656 1091, ICS Dizcovery Universal Face Cushion (qty 4) 45657 1091, ICS Dizcovery Universal Face Cushion (qty 40) 45641 1091, ICS Dizcovery Universal Face Cushion (qty 40) 8-04-16400 1091, ICS Dizcovery System 45654 1091, ICS Dizcovery ShadeShift Panels

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)