Austar
41 catalogue numbers from FH304, listed by Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd., under Hearing Aid, Air-Conduction, Over The Counter. 57 manufacturers in China are registered for this product code.
57manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (33), Fujian (9), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Xiamen Retone Hearing Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Hangzhou Acosound Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Xiamen Melosound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 4 |
| Zhongshan Great-Ears Electronic Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Eran Technology (Shenzhen)Co., Limited | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Rayson Technology (Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Winner Medical Co., Ltd. | Shenzhen | Guangdong | Specification developer | 25 |
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
Showing 12 of 57. All 57 manufacturers in China registered for Hearing Aid, Air-Conduction, Over The Counter
Record
| Listed by | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. |
|---|---|
| FDA product code | QUF |
| Device type | Hearing Aid, Air-Conduction, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Premarket notification | Exempt |
| Record published | 2023-09-27 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | expiry date, serial number |
| Distribution end date | 2025-09-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FH304 | In distribution | |
| FHE412 | In distribution | |
| FH205 | In distribution | |
| FHE404 | In distribution | |
| FHE509 | In distribution | |
| FHE410 | In distribution | |
| FHE407 | In distribution | |
| FH208 | In distribution | |
| FHE405 | In distribution | |
| FH211 | In distribution | |
| FH308 | In distribution | |
| FH303 | In distribution | |
| FH310 | In distribution | |
| FH305 | In distribution | |
| FHE411 | In distribution | |
| FH207 | In distribution | |
| FHE503 | In distribution | |
| FH210 | In distribution | |
| FHE506 | In distribution | |
| FHE504 | In distribution | |
| FH309 | In distribution | |
| FHE409 | In distribution | |
| FH204 | In distribution | |
| FHE406 | In distribution | |
| FHE507 | In distribution | |
| FHE510 | In distribution | |
| FHE511 | In distribution | |
| FH203 | In distribution | |
| FHE505 | In distribution | |
| BS05E | In distribution | |
| FH312 | In distribution | |
| FH209 | In distribution | |
| FH307 | In distribution | |
| FHE508 | In distribution | |
| FH311 | In distribution | |
| FH212 | In distribution | |
| FHE512 | In distribution | |
| FH206 | In distribution | |
| FHE403 | In distribution | |
| FHE408 | In distribution | |
| ALD-L1A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tianle | Zhongshan Tianle Hearing Technology Co., Ltd. | 146 |
| Tomore | Tomore Medical (Shenzhen) Co., Ltd. | 70 |
| Tomore | Tomore Healthcare (Dongguan) Co., Ltd. | 65 |
| Retone | Xiamen Retone Hearing Technology Co., Ltd. | 39 |
| Melosound | Xiamen Melosound Technology Co., Ltd. | 27 |
| Mirasing | Xiamen Mirasing Technology Co., Ltd. | 18 |
| Ceretone | Audicon Corporation | 16 |
| Cofoe | Cofoe Medical Technology Co., Ltd. | 16 |
| RCA | Voxx Accessories Corp. | 15 |
| AcoSound | Hangzhou Acosound Technology Co., Ltd. | 15 |
| RCA | Huizhou Gold Rose Technology Co., Ltd. | 12 |
| Jinghao | Huizhou Jinghao Medical Technology Co., Ltd. | 10 |
Showing 12 of 96. All products under Hearing Aid, Air-Conduction, Over The Counter
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.