Braun
UPC/UDI BRAUN HEARING AID SINGLE DEVICE CHAMPAGNE (Contains unit of use 10328785002901)
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
Record
| Listed by | KAZ USA, Inc. |
|---|---|
| FDA product code | QDD |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Record published | 2022-06-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BHA101F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Hearing | GN Hearing A/S | 17 |
| Sony | WS Audiology USA, Inc. | 3 |
| Eargo RX | Eargo Inc | 2 |
| Lexie Hearing | Hearx SA | 2 |
| Lexie B1, Powered by Bose | Hearx SA | 1 |
| Lexie B2, Powered by Bose | Hearx SA | 1 |
| Bose Hear App | Bose Corporation | 1 |
| Bose SoundControl Hearing Aid | Bose Corporation | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.