Audigence, Inc.
Country not established
- Devices
- 1
What Audigence, Inc. makes
Audigence, Inc. manufactures CLARUJUST, a medical device designed for auditory rehabilitation and hearing enhancement, likely targeting specific hearing conditions or speech clarity challenges.
The company’s portfolio is regulated under FDA Class II devices, with CLARUJUST authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) clearance registry. Audigence, Inc. is based in the United States.
Catalogue
Clarujust Ref K092089
510(k) 510(k)
Frequently asked questions
How many devices does Audigence, Inc. have in the registry?
The registry currently lists 1 device for Audigence, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Audigence, Inc.'s devices?
Among its 1 most recently registered device, Audigence, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Audigence, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Audigence, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Audigence, Inc. in the registry?
The most recently registered devices listed for Audigence, Inc. include CLARUJUST.