FDA Registration
Active
🇩🇰 Denmark
Natus Medical Denmark ApS
Reg #: 9612197
·
FEI: 3002807554
·
Expires 2026
Products
14
Proprietary Names
182
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- Natus Medical Denmark ApS
- Registration Number
- 9612197
- FEI Number
- 3002807554
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hoerskaetten 9
- City
- TAASTRUP Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K132957
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 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2025-05-13 |
| Nystagmograph | GWN | Class 2 | Neurology | No | 2025-04-22 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2025-04-23 |
| Tester, Auditory Impedance | ETY | Class 2 | Ear, Nose, Throat | No | 2025-04-13 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2025-05-02 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2025-05-02 |
| Calibrator, Hearing Aid / Earphone And Analysis Systems | ETW | Class 2 | Ear, Nose, Throat | 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 |
| Apparatus, Vestibular Analysis | LXV | Class U | Unknown | No | 2025-04-23 |
| Stimulator, Caloric-Air | KHH | Class 1 | Ear, Nose, Throat | No | 2025-04-23 |
| Cushion, Earphone (For Audiometric Testing) | ETT | Class 1 | Ear, Nose, Throat | No | 2025-05-13 |
| Otoscope | ERA | 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+
RetCam Envision
ALGO 5 Newborn Hearing Screener
ALGO 3i Newborn Hearing Screener
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
Hi Pro
Type 1072 - HI-PRO 2
Type Noahlink - Noahlink
Audiometer
neoBLUE LED Phototherapy System
Natus Biliband Eye Protector
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
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
Coupler microphone
PMM RECD Probe BIN Short
8-04-15101, 1082 AURICAL HIT
Aurical Hit
Reference microphone
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
036237ALGO Pro PCA Cables, 72 inch
036234ALGO Pro ATA Cables, 36 inch
042055ALGO Pro DC-DC converter module
040587Jelly Tab Electrodes
040546ALGO-Pack
036235ALGO Pro ATA Cables, 72 inch
040670Valu-Pack
036243ALGO Pro Mobile Cart
036177ALGO Pro Newborn Hearing Screening Device
041554ALGO Pro Bassinet Hook
036236ALGO Pro PCA Cables, 36 inch
036244ALGO Pro Docking Station
011445Flexicoupler and Jellytab Combo Pack
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
neoBLUE Compact LED Phototherapy System
neoBLUE Nova
Neonatal Phototherapy Unit
ICS Impulsa
ICS Impulse
Echo-Screen III Hearing Screener
JELLY TAB SENSORS
Echo-Screen III Pro Hearing Screener
Natus branded OAE Probe Body Nozzle (5/PKG)
JELLY TABS,40 SCRN/120 TAB
Natus Jelly Tab Disposable Electrodes, 60/pkg
neoBLUE blanket LED Phototherapy System
Type 1079 - ICS Aircal
AirCal
Specula, disposable
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
Silicone Eartip, 10 mm, transparent, umbrella (50 pcs)
Silicone Eartip, 22 mm, transparent, umbrella (50 pcs)
Silicone Eartip, 7 mm, semi red, mushroom (50 pcs)
Silicone Eartip, 12.5 mm, semi red, mushroom (50 pcs)
OAE Pediatric Foam Tip (20)
Foam Eartip 3B Small
Silicone Eartip, 14 mm, semi green, mushroom (50 pcs)
Silicone Eartip, 9.5 mm, semi blue, mushroom (50 pcs)
Silicone Eartip, 19 mm, transparent, umbrella (50 pcs)
OAE TreeTip (20)
OAE Jumbo Foam Tip (100)
Foam Eartip 3C Jumbo
Silicone Eartip, 8 mm, semi green, mushroom (50 pcs)
OAE Preemie TreeTip (20)
Silicone Eartip, 16 mm, semi blue, mushroom (50 pcs)
OAE Adult Foam Tip (100)
Silicone Eartip, 5 mm, blue, tree tip (50 pcs)
Silicone Eartip, 13 mm, transparent, umbrella (50 pcs)
Silicone Eartip, 6 mm, semi gray, mushroom (50 pcs)
OAE Pediatric Foam Tip (100)
OAE TreeTip (100)
Foam Eartip 3A Standard
OAE Preemie TreeTip (100)
Silicone Eartip, 18 mm, semi gray, mushroom (50 pcs)
Silicone Eartip, 16 mm, transparent, umbrella (50 pcs)
Silicone Eartip, 11 mm, semi gray, mushroom (50 pcs)
OAE Adult Foam Tip (20)
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)
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
1093, HEADSET HS3
Type 1093 - Otoscan
Specula, 3mm, normal, 12
Type 1076 - OTOcam 300
Otoscan, Otocam 300
Specula, 3mm, cerumen, 12
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device