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
Phone
224 4254814

Products

Device Name Product Code
Stimulator, Auditory, Evoked Response GWJ
Camera, Ophthalmic, Ac-Powered HKI
Nystagmograph GWN
Hearing Aid, Air-Conduction, Prescription ESD
Tester, Auditory Impedance ETY
Unit, Neonatal Phototherapy LBI
Pad, Neonatal Eye FOK
Calibrator, Hearing Aid / Earphone And Analysis Systems ETW
Audiometer EWO
Aid, Vision, Electronic, Battery-Powered HPG
Apparatus, Vestibular Analysis LXV
Stimulator, Caloric-Air KHH
Cushion, Earphone (For Audiometric Testing) ETT
Otoscope ERA

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