Unimax Hearing Instruments
Country not established
- Devices
- 2
What Unimax Hearing Instruments makes
Unimax Hearing Instruments manufactures custom canal hearing aids, including in-the-ear (ITE) and canal-referred (CCR) devices tailored for ear canal fit. Their portfolio also includes behind-the-ear (BTE) hearing aid models, such as the 100S, 110C, and PPS4 series, designed for over-the-ear amplification.
These devices are classified under Class I by the FDA and are authorised through the 510(k) clearance pathway. The company operates from the United States, with its products listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unimax Hearing Instruments have in the registry?
The registry currently lists 2 devices for Unimax Hearing Instruments. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unimax Hearing Instruments's devices?
Among its 2 most recently registered devices, Unimax Hearing Instruments has devices listed in FDA 510(k) (2 devices).
What risk classes do Unimax Hearing Instruments's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Unimax Hearing Instruments's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Unimax Hearing Instruments in the registry?
The most recently registered devices listed for Unimax Hearing Instruments include UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS and UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4.