Interacoustics A/S
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Interacoustics A/S is a medical device manufacturer, with 318 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II, Class I and Unclassified) as of 13 Nov 2026.
- Devices
- 318
Registry facts
- Registries
- FDA GUDID 297
- EUDAMED 153
- FDA 510(k) 21
- Device classes
- FDA Class II 246
- FDA Class I 67
- FDA Unclassified 4
- Sites and related companies
- Interacoustics A/S Denmark
- Identifiers
- DUNS 306308354
What Interacoustics A/S makes
The company manufactures audiometric earphones, including supra-aural and circumaural designs, as well as ear tips for hearing assessments. It produces cranial bone vibrators for auditory testing and auditory-evoked potential audiometers, including tone audiometers. Additional products include vestibulo-auditory analysis support kits, non-scalp cutaneous leads for evoked-potential testing, and related diagnostic accessories.
These devices are regulated under FDA classifications including Class I, Class II, and Unclassified (U), with some authorised via the 510(k) pathway and others through the De Novo process. The portfolio is also listed under the FDA’s UDI (Unique Device Identification) system.
Catalogue
Search and filter all 318 devicesShowing 1-50 of 318
Company details
- DUNS number
- 306308354
Sites
- Interacoustics A/S DKFEI 3000254565 0 devices
Frequently asked questions
How many devices does Interacoustics A/S have in the registry?
The registry currently lists 318 devices for Interacoustics A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Interacoustics A/S's devices?
Among its 50 most recently registered devices, Interacoustics A/S has devices listed in EUDAMED (29 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Interacoustics A/S's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Interacoustics A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Interacoustics A/S in the registry?
The most recently registered devices listed for Interacoustics A/S include Interacoustics Sera, Interacoustics Titan, Interacoustics AT235 and Interacoustics PA5.