Mediphonix, Inc.
Country not established
- Devices
- 1
What Mediphonix, Inc. makes
Mediphonix, Inc. manufactures custom hearing aid shells designed for canal placements, tailored to fit individual patient anatomy. These devices are intended for use with hearing aid components to improve auditory function in patients requiring bespoke ear canal solutions.
The company’s products fall under Class I regulatory classification in the U.S., with devices authorised via 510(k) clearance through the FDA. The portfolio is listed under the U.S. regulatory framework, and the manufacturer is based in the United States.
Catalogue
Mediphonix Custom Full Shell Custom Canal Ref K924450
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mediphonix, Inc. have in the registry?
The registry currently lists 1 device for Mediphonix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mediphonix, Inc.'s devices?
Among its 1 most recently registered device, Mediphonix, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Mediphonix, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Mediphonix, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Mediphonix, Inc. in the registry?
The most recently registered devices listed for Mediphonix, Inc. include MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL.