Natus Medical Denmark ApS

FDA Device Registration & Listing · TAASTRUP Hovedstaden, DK · Registration 9612197

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9612197
FEI Number
3002807554
Entity Name
Natus Medical Denmark ApS
City/State/Country
TAASTRUP Hovedstaden, DK
Establishment Address
Hoerskaetten 9, TAASTRUP Hovedstaden DK-2630, DK
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
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
N
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+ 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 ALGO 3i Newborn Hearing Screener 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 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 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

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
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2025-05-13
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2025-05-02
GWN Nystagmograph Neurology Class 2 882.1460 2025-04-22
ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat Class 1 874.3300 2025-04-23
ETY Tester, Auditory Impedance Ear, Nose, Throat Class 2 874.1090 2025-04-13
LBI Unit, Neonatal Phototherapy General Hospital Class 2 880.5700 2025-05-02
FOK Pad, Neonatal Eye General Hospital Class 1 880.5270 2025-05-02
ETW Calibrator, Hearing Aid / Earphone And Analysis Systems Ear, Nose, Throat Class 2 874.3310 2025-04-23
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2025-04-30
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
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2025-04-23
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2025-05-13
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2025-04-23
LBI Unit, Neonatal Phototherapy General Hospital Class 2 880.5700 2025-04-30
GWN Nystagmograph Neurology Class 2 882.1460 2025-04-23
LXV Apparatus, Vestibular Analysis Unknown Class U N/A 2025-04-23
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2025-04-30
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2025-04-30
LBI Unit, Neonatal Phototherapy General Hospital Class 2 880.5700 2025-04-30
KHH Stimulator, Caloric-Air Ear, Nose, Throat Class 1 874.1800 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
3034880867 Natus Sensory Ireland Ltd Gort Galway, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K041546 Canon, Inc. DIGITAL FUNDUS CAMERA, MODEL CF-60DSI 2004-06-23
K010059 Western Systems Research, Inc. ENGPLUS 2001-02-27
K892457 Telstar Electronics, Inc. TELSTAR MODEL 1/3 ITE HEARING AID 1989-06-06
K760996 Unitron Industries, Inc. HEARING AID (MODEL 695D, 905 & 960P) 1976-11-16
K840825 Maico Hearing Instruments, Inc. SERIES MR IN-THE-EAR CUSTOM HEARING AID 1984-03-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2018 Optovue, Inc. 2
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612197. Last updated year: 2026. Please use registration number 9612197 when referencing this establishment in official correspondence.
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