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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 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GN Otometrics A/S | Eartip, Earlink 3C, jumbo | FDA UDI | Class II | Unknown |
| Ics | 1073, Main U Chartr EP Pre-Amp | FDA UDI | Class II | Active |
| GN Otometrics A/S | Ear Coupler Cable for Binaural ABR | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | 1021, EAR TIP KIT,12,5MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 4mm Red, 100 Pcs. | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Eartip 8-11 mm Transparent Tree (bag of 50 pcs) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Alpha DPOAE Probe (Grey) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | BTE adapter tubes | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "Eartip 6-10 mm yellow foam | EUDAMEDFDA UDI | Class II | Active |
| GN Otometrics A/S | "Immittance Prove Wax Filter Kit | FDA UDI | Class II | Active |
| GN Otometrics A/S | ELECTR LEAD, SNAP, 40 IN. BLUE | FDA UDI | Class II | Active |
| Ics | Preamp Lanyard, EP 200 | FDA UDI | Class II | Active |
| Otometrics | 1085, STRAP ASSEMBLY | FDA UDI | Class II | Active |
| GN Otometrics A/S | RECD Fitting Kit | FDA UDI | Class II | Active |
| GN Otometrics A/S | Patient Responder (Grey) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | MADSEN Capella2, TE | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 12-16 mm Blue Tree (Bag of 50 pcs) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ELECTR LD, SNAP, 24 IN, YELLOW | FDA UDI | Class II | Active |
| GN Otometrics A/S | Disposable Electrodes Snap Qty 20 | FDA UDI | Class II | Active |
| GN Otometrics A/S | ELECTR LD,ENG,SNAP,40 IN PKG/7 | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Regular eartips (50 pcs.) | FDA UDI | Class II | Unknown |
| Ics | 8-04-13301 | FDA UDI | Class I | Active |
| GN Otometrics A/S | AS, TEST CAVITY, 1.75 CCM | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "TO/TB monitoring system | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 5mm Blue, 100 Pcs | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | DISC ELECTR,GLD, 9MM,48 IN,WHT | FDA UDI | Class II | Active |
| GN Otometrics A/S | EAR tone, Tube Niples | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | 1096, EARTIP STARTER KIT | FDA UDI | Class II | Unknown |
| Accuscreen | 8-04-13906 | FDA UDI | Class II | Active |
| GN Otometrics A/S | Goggle Upgrade for Lateral/LARP/RALP | FDA UDI | Class II | Active |
| GN Otometrics A/S | Headset Monitoring w/ boom mic | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Monitor Headset w/cable | FDA UDI | Class II | Active |
| AccuScreen | 8-04-13905 | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT,14 MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | ELECTR LD, SNAP, 24 IN, WHITE | FDA UDI | Class II | Active |
| Vemp Monitor | 8-36-00520 | FDA UDI | Class II | Active |
| GN Otometrics A/S | Headset Holmco (95-01) | FDA UDI | Class II | Active |
| GN Otometrics A/S | Small Tip Kit | FDA UDI | Class II | Active |
| GN Otometrics A/S | "MADSEN OTOflex 100 Quick Check | FDA UDI | Class II | Active |
| GN Otometrics A/S | TDH 39 with cushion (contralateral earphone) | FDA UDI | Class II | Active |
| Otometrics | Madsen A450 | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT, 7MM 50PCS | FDA UDI | Class II | Active |
| GN Otometrics A/S | Probe tip for TEOAE (pack of 5 pcs) | FDA UDI | Class II | Active |
| Vemp Monitor | 8-36-00500 | FDA UDI | Class II | Active |
| GN Otometrics A/S | Specula 3 mm Cerumen | FDA UDI | Class I | Active |
| Natus | 8-62-49110 | FDA UDI | Class II | Active |
| GN Otometrics A/S | LD, GOLD FOIL TIP-TRODE, PKG/2 | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "Probe Tip Kit | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip, Earlink 3A, standard | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | 1096, CALIBRATION CAVITY KIT | FDA UDI | Class II | Active |
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