Austar Hearing Science & Technology (Xiamen) Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 5 device types.
Austar Hearing Science & Technology (Xiamen) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Face Plate Hearing Aid, Hearing Aid, Air-Conduction, Prescription and 3 other device types. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008606477 |
| FEI number | 3008606477 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | Ground Floor, Second Floor, Third Floor, Fourth Floor section B and Fifth Floor, Building B8, |
| Postal code | 361022 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Face Plate Hearing Aid | Class 1 | In-The-Ear Hearing Aid (Faceplate Kits included), In-The-Ear Hearing Aid (FD02A,HE07,DM04), One-Fit-All In-The-Ear Hearing Aid (Faceplate Kits included) | 2010 | 11 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE408-B, FHE407-B, FHE406-B, FHE405-B, FHE404-B, FHE403-B), Digital Rechargeable BTE-OE OTC Hearing Aids (FH212-B, FH211-B, FH210-B, FH209-B, FH208-B, FH207-B, FH206-B, FH205-B, FH204-B, FH203-B), Air-Conduction Hearing Aid with Wireless Technology and Ear Union APP, Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE512-B, FHE511-B, FHE510-B, FHE509-B, FHE508-B, FHE507-B, FHE506-B), Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE612-B, FHE611-B, FHE610-B, FHE609-B, FHE608-B), Digital Rechargeable BTE-OE OTC Hearing Aids (FH807-B,FH806-B,FH805-B FH804-B,FH803-B) and 25 more | 2023 | 52 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Class 2 | Behind The Ear Heaing Aid (FHC9RLP-DW,FHC7RLP-DW,FHC5RLP-DW,FHC3RLP-DW,FHC9RLP-W,FHC7RLP-W,FHC5RLP-W,FHC3RLP-W), Behind The Ear Heaing Aid(FHC9BHP-DW,FHC7BHP-DW,FHC5BHP-DW,FHC3BHP-DW,FHC9BHP-W,FHC7BHP-W,FHC5BHP-W,FHC3BHP-W), Behind The Ear Heaing Aid (FHC9RMP-DW,FHC7RMP-DW,FHC5RMP-DW,FHC3RMP-DW,FHC9RMP-W,FHC7RMP-W,FHC5RMP-W,FHC3RMP-W), Digital Rechargeable BTE-OE Hearing Aids(FH512-B,FH511-B,FH510-B,FH509-B,FH508-B,FH507-B,FH506-B,FH505-B,FH504-B,FH503-B, Digital Rechargeable BTE-RIC Hearing Aids (FHE707-B,FHE706-B, FHE705-B, FHE704-B, FHE703-B), In-The-Ear Hearing Aid with Ear Union APP and 25 more | 2022 | 29 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | Air-Conduction Hearing Aid, Digital Rechargeable RIC OTC Hearing Aids (FHE512,FHE511,FHE510,FHE509,FHE508,FHE507,FHE506,FHE505), Behind-The-Ear Hearing Aid (Otofonix), Digital Rechargeable ITE OTC Hearing Aids (F812B, F811B, F810B, F809B, F808B, F807B, F806B, F805B, F804B, F803B), Digital Rechargeable RIC OTC Hearing Aids(FHE712, FHE711, FHE710, FHE709, FHE708, FHE707,FHE706, FHE705, FHE704, FHE703), Digital Rechargeable BTE-OE OTC Hearing Aids (FH412, FH411, FH410, FH409, FH408, FH407, FH406, FH405, FH404, FH403) and 25 more | 2022 | 57 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | Behind-The-Ear Hearing Aid (B304,B304P,B304U,B305P,B305U,SU05U,SU05P), Behind-The-Ear Hearing Aid (Otofonix), Digital Rechargeable BTE-OE Hearing Aids(FH312,FH311,FH310,FH309,FH308,FH307,FH306,FH305), Digital Rechargeable BTE-OE Hearing Aids(FH304,FH303,FH212,FH211,FH210,FH209,FH208,FH207,FH206,FH205,FH204,FH203), Digital Rechargeable RIC Hearing Aids (FHE412,FHE411,FHE410,FHE409,FHE408,FHE407,FHE406,FHE405,FHE404,FHE403), Digital Rechargeable ITE Hearing Aids (F812B, F811B, F810B, F809B, F808B, F807B, F806B, F805B, F804B, F803B) and 21 more | 2010 | 45 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Employees | 500 |
| Factory area | 7200 |
| Main products | Rechargeable hearing aids, Bluetooth hearing aids, BTE hearing aids, RIC hearing aids, Custom hearing aids |
| Certifications | ISO 13485:2016, CE MDR, FDA |
| Export markets | Europe, North America, Asia, Middle East |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
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