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Sign in to claim this brandWhat Natus Medical Denmark ApS makes
Natus Medical Denmark ApS manufactures diagnostic devices for audiology and vestibular testing, including auditory stimulators, impedance audiometers, and semi-automated tone audiometers. Their portfolio also covers speech audiometers, electrical hearing aid testers, and electronystagmographs, as well as diagnostic systems for caloric vestibular stimulation. These tools are designed for clinical assessment of hearing and balance disorders.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Natus Medical Denmark ApS manufacture?
Natus Medical Denmark ApS specializes in diagnostic devices for audiology and vestibular testing. Their portfolio includes auditory stimulators, impedance audiometers, semi-automated tone audiometers, speech audiometers, electrical hearing aid testers, and electronystagmographs. They also produce diagnostic systems for caloric vestibular stimulation, which are used to assess balance disorders in clinical settings.
Where is Natus Medical Denmark ApS based?
Natus Medical Denmark ApS is based in the United States. The company operates from this location while developing and manufacturing its medical devices, which are designed to meet regulatory standards applicable in the US.
Which regulatory registries list devices manufactured by Natus Medical Denmark ApS?
Devices manufactured by Natus Medical Denmark ApS are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices that have been authorized for commercial distribution in the United States.
How are the devices produced by Natus Medical Denmark ApS classified under FDA regulations?
The devices produced by Natus Medical Denmark ApS fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification determines the regulatory pathway and oversight required for each device type.
What is the purpose of the devices manufactured by Natus Medical Denmark ApS?
The devices manufactured by Natus Medical Denmark ApS are designed for clinical use in audiology and vestibular assessment. They help diagnose and evaluate hearing and balance disorders by providing precise measurements and tests, such as auditory responses, impedance analysis, and vestibular function assessments. These tools support accurate diagnosis and treatment planning for patients.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 306633756
Catalogue (363)
Page 1 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GN Otometrics A/S | Handy eartip box (empty) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Reference microphone for HIT | FDA UDI | Class II | Active |
| GN Otometrics A/S | Reference Microphone, Calibrated | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1096, QUICK CHECK PROBE | FDA UDI | Class II | Unknown |
| Natus | 8-66-22500 | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Eartip 5.0 mm pastel blue | EUDAMEDFDA UDI | Class II | Active |
| GN Otometrics A/S | CHARTR EP 200 VEMP MONIT. KIT | FDA UDI | Class II | Active |
| GN Otometrics A/S | Handy eartip box (empty) | FDA UDI | Class II | Active |
| GN Otometrics A/S | Probe for TEOAE | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | DISC ELECTR,GLD, 9MM,48 IN,BRN | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Eartip 4,0 mm dark blue (250 pcs) | FDA UDI | Class II | Active |
| GN Otometrics A/S | REM/SPL Probe (Single) | FDA UDI | Class II | Active |
| GN Otometrics A/S | Acoustic filters (10 pcs) | FDA UDI | Class II | Active |
| GN Otometrics A/S | ELECTR LEAD, SNAP, 24 IN, BLUE | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT,18 MM 50PCS | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | 1073, OTOINSERT CABLE KIT | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip Box, Large | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 9mm Blue, 100 Pcs. | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "Regular eartips (50 pcs.) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | OTOair Bluetooth Dongle | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Eartip 3.7 mm pastel yellow | EUDAMEDFDA UDI | Class II | Active |
| GN Otometrics A/S | ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only | FDA UDI | Class II | Active |
| Madsen Astera 2 | 8-04-13402 | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 6mm Green, 100 Pcs. | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Eartip 9-13 mm Foam, Yellow (Bag of 50 pcs) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "MADSEN XETA, US Only | FDA UDI | Class II | Active |
| GN Otometrics A/S | REM Test tubes, 1.1mm (50 pcs.) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Binaural SPL/REM probe | FDA UDI | Class II | Active |
| GN Otometrics A/S | Probe Tip (10 pcs) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | BONE CONDUCTION TRANS, EP 200 | FDA UDI | Class II | Active |
| GN Otometrics A/S | Headphone (customer) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Sealing wax | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Printer kit | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT, 11MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | Electrodes, snap, disposables (450 x 3 packs) | FDA UDI | Class II | Active |
| GN Otometrics A/S | "AirCal Caloric Stimulator, Extended | FDA UDI | Class I | Active |
| GN Otometrics A/S | 1081 AURICAL with HI-PRO | FDA UDI | Class II | Active |
| GN Otometrics A/S | Etymotics 10D OAE Probe | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT,18 MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | MADSEN AccuScreen | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Eartip 4-7 mm tree, transparent | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip ZO901, 13mm, 50 pcs | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1096, DIAGNOSTIC PROBE,COMFORT | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ZO901 PROBE HANDLE COMPLETE | FDA UDI | Class II | Active |
| GN Otometrics A/S | INSERT PHONE, 10-OHM, M-DIN | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1021, EAR TIP KIT,16 MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1013, ABR EAR COUPLER 25 PAIRS | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ELECTR LEAD, SNAP, 40 IN, RED | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1021, EAR TIP KIT, 8MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | Accessory Kit for sound box installation (US) | FDA UDI | Class II | Active |
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