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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 5 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GN Otometrics A/S | ZC100 CAVITY 0.1CC | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | MADSEN Itera II, US Only | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 10mm Green, 100 Pcs. | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ELECTR LD, SNAP, 40 IN, BROWN | FDA UDI | Class II | Active |
| GN Otometrics A/S | ELECTRODE JUMPER, 4 INCHES | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1085 Vision Denied Solution Kit (50 sets) | FDA UDI | Class II | Active |
| GN Otometrics A/S | DISC ELTRD,GLD,EP,9MM,48,PKG/5 | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 7mm Yellow, 100 Pcs. | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "Eartip 4.5 mm red brown (50 pcs) | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT, 11MM 50PCS | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Eartip 14mm Foam, 50 Pcs. | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Elevation plate | FDA UDI | Class II | Active |
| Ics | 8-04-13320 | FDA UDI | Class I | Active |
| GN Otometrics A/S | "TO/TB monitoring system | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 3-6mm Yellow, 100 Pcs. | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Eartip yellow tree type 4-7mm (50 pcs) | FDA UDI | Class II | Active |
| GN Otometrics A/S | NB71, Boneconductor w/headband and cable | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "Regular eartips (50 pcs.) | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ELECTR LEAD, SNAP, 24 IN. RED | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Immittance Probe Complete | FDA UDI | Class II | Active |
| GN Otometrics A/S | "Eartip 4.0 mm pastel green | FDA UDI | Class II | Active |
| GN Otometrics A/S | REM Tube, Blue Handle (50 pcs.) | FDA UDI | Class II | Unknown |
| Natus | 8-62-45300 | FDA UDI | Class II | Active |
| GN Otometrics A/S | PMM RECD Probe Long | FDA UDI | Class II | Active |
| GN Otometrics A/S | Label printer kit | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | MADSEN AccuScreen | EUDAMEDFDA UDI | Class II | Active |
| AccuScreen | 8-04-13904 | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | Eartip 6-9 mm Blue Tree (Bag of 250 pcs.) | FDA UDI | Class II | Unknown |
| Ics | 8-04-13330 | FDA UDI | Class I | Active |
| GN Otometrics A/S | ZC100 CAVITY 1CC | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | 1021, EAR TIP KIT, 9.5MM 50PCS | FDA UDI | Class II | Active |
| NeoBLUE Nova | 019040 | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip ZO901, 19mm, 50 pcs | FDA UDI | Class II | Active |
| GN Otometrics A/S | DSC ELTRD,GLD,EP,9MM,48IN,PK/8 | FDA UDI | Class II | Active |
| Madsen Astera 2 | 8-04-13403 | FDA UDI | Class II | Active |
| GN Otometrics A/S | DISC ELECTR,GLD, 9MM,48 IN,BLU | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip Box, Large | FDA UDI | Class II | Unknown |
| Madsen A450 | 8-04-14660 | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1004, DIN TO JACK MALE ADAPTER | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1085, GOGGLE HOME KIT | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ABR Kit (normal cable) | FDA UDI | Class II | Active |
| GN Otometrics A/S | AURICAL | FDA UDI | Class II | Active |
| GN Otometrics A/S | Electrodes, snap, disposables (1 x 3 packs) | FDA UDI | Class II | Active |
| GN Otometrics A/S | SPL silicone tubes (5 pcs.) | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1022, EAR TIP KIT, 8MM 50PCS | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | "Headset Monitoring w/ boom mic | FDA UDI | Class II | Unknown |
| GN Otometrics A/S | ELECTR LD, SNAP, 24 IN, BROWN | FDA UDI | Class II | Active |
| GN Otometrics A/S | DISC ELECTR,GLD, 9MM,48 IN,YEL | FDA UDI | Class II | Active |
| GN Otometrics A/S | 1096, PROBE TIP KIT | FDA UDI | Class II | Active |
| GN Otometrics A/S | Eartip 5.5mm transparent blue (package of 50 pcs) | FDA UDI | Class II | Active |
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