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
- [email protected]
- Phone
- 224 4254814
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2025-04-23 |
| Nystagmograph | GWN | Class 2 | Neurology | No | 2025-04-23 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2025-04-23 |
| Aid, Vision, Electronic, Battery-Powered | HPG | Class 1 | Ophthalmic | No | 2018-12-10 |
| Calibrator, Hearing Aid / Earphone And Analysis Systems | ETW | Class 2 | Ear, Nose, Throat | No | 2025-04-23 |
| Apparatus, Vestibular Analysis | LXV | Class U | Unknown | No | 2025-04-23 |
| Tester, Auditory Impedance | ETY | Class 2 | Ear, Nose, Throat | No | 2025-04-23 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2025-04-23 |
| Stimulator, Caloric-Air | KHH | Class 1 | Ear, Nose, Throat | No | 2025-04-23 |
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)