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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
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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 2 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GN Otometrics A/S | Bone Conductor w/ headband and cable | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 12-16 mm Blue Tree (Bag of 250 pcs) | FDA UDI | Class II | Unknown |
| 1077 AccuScreen | 8-04-13904 | FDA UDI | Class II | Active |
| Natus | 8-49-88800 | FDA UDI | Class II | Active |
| GN Otometrics A/S | MADSEN Itera II, US Only | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 6-9 mm Blue Tree (Bag of 50 pcs.) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Monocular Positional | FDA UDI | Class II | Active |
| Natus | 8-61-20100 | FDA UDI | Class I | Active |
| GN Otometrics A/S | Eartip ZO901, 16mm, 50 pcs | FDA UDI | Class II | Active |
| Ics | Preamp Shoulder Harness, EP 200 | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1021, EAR TIP KIT, 11MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | Lateral Head Impulse | FDA UDI | Class II | Active |
| GN Otometrics A/S | Earhugs, disposables | FDA UDI | Class II | Active |
| GN Otometrics A/S | TIP-TRODE,ADLT GLD FOIL,PKG/20 | FDA UDI | Class II | Unknown |
| Neoblue | 019030 | FDA UDI | Class II | Active |
| GN Otometrics A/S | DISC ELECTR,GLD, 9MM,48 IN,BLK | FDA UDI | Class II | Active |
| GN Otometrics A/S | ICS Impulse | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT, 6MM 50PCS | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | 1096, DIAGNOSTIC PROBE,CLASSIC | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Headset Monitoring | FDA UDI | Class II | Unknown |
| AccuScreen | 8-04-13961 | EUDAMEDFDA UDI | Class II | Active |
| Otometrics | 1085, FACE PAD ASSEMBLY KIT V2 | FDA UDI | Class II | Active |
| GN Otometrics A/S | AURICAL | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Headset ME70 (8 kHz) matched | FDA UDI | Class II | Active |
| GN Otometrics A/S | "AirCal Caloric Stimulator, Extended | FDA UDI | Class I | Active |
| GN Otometrics A/S | HEADSET IPSI PAD | FDA UDI | Class II | Active |
| GN Otometrics A/S | Starter Kit | FDA UDI | Class II | Unknown |
| AccuScreen | 8-49-89900 | FDA UDI | Class II | Active |
| GN Otometrics A/S | MADSEN AccuScreen | FDA UDI | Class II | Active |
| AccuScreen | 8-04-13958 | FDA UDI | Class II | Active |
| Otometrics | Adult IPSI probeset, HL. Calibration: HL | FDA UDI | Class II | Active |
| GN Otometrics A/S | Probe Cover Tip 4 Pcs. | FDA UDI | Class II | Unknown |
| AccuScreen | 8-04-13900 | FDA UDI | Class II | Active |
| AccuScreen | 8-04-13903 | FDA UDI | Class II | Active |
| GN Otometrics A/S | VH-40 Video Goggles | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT, 9.5MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 5 mm Blue (Bag of 250) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ZO901 TDH39 CONTRA ADD-ON SET | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Eartip 3.7 mm pastel yellow | EUDAMEDFDA UDI | Class II | Active |
| GN Otometrics A/S | External Battery Charger | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Specula, disposable | FDA UDI | Class I | Active |
| GN Otometrics A/S | OTOair 2 Bluetooth Dongle | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Regular eartips (50 pcs.) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | 1081 AURICAL w/o HI-PRO | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1077, DOCKING UNIT KIT | EUDAMEDFDA UDI | Class II | Active |
| GN Otometrics A/S | Probe Tube Holder mk2 | FDA UDI | Class II | Active |
| Otometrics | Madsen A450 | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1021, EAR TIP KIT, 5MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip ZO901, 22mm, 50 pcs | FDA UDI | Class II | Active |
| GN Otometrics A/S | MADSEN Itera II, US Only | FDA UDI | Class II | Active |
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