ELEHEAR Inc.
Country not established FDA
Part of Elehear Inc.
- Devices
- 11
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What ELEHEAR Inc. makes
ELEHEAR Inc. manufactures air-conduction hearing aids designed for receiver-in-canal use, which are custom-fitted into the ear canal to amplify sound for individuals with hearing loss.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Catalogue
Search and filter all 11 devicesCompany details
- DUNS number
- 699441039
FDA establishments
- Elehear Inc. Shenzhen Guangdong · CN FEI 3030682076
Frequently asked questions
How many devices does ELEHEAR Inc. have in the registry?
The registry currently lists 11 devices for ELEHEAR Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ELEHEAR Inc.'s devices?
Among its 11 most recently registered devices, ELEHEAR Inc. has devices listed in FDA GUDID (11 devices).
What risk classes do ELEHEAR Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for ELEHEAR Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ELEHEAR Inc. in the registry?
The most recently registered devices listed for ELEHEAR Inc. include ELEHEAR RIC 03B, ELEHEAR FC04, ELEHEAR RIC 03L and ELEHEAR RIC 03M.
Which FDA establishments are linked to ELEHEAR Inc.?
1 FDA establishment is linked to ELEHEAR Inc. in the registry; they are listed on the company page.