FDA Registration
Active
🇨🇳 China
AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD
Reg #: 3008606477
·
FEI: 3008606477
·
Expires 2026
Products
5
Proprietary Names
115
Establishment Types
2
Classifications
5
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD
- Registration Number
- 3008606477
- FEI Number
- 3008606477
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ground Floor, Second Floor, Third Floor, Fourth Floor section B and Fifth Floor, Building B8,, Biomedical Industrial Park NO. 2064, Wengjiao West Road, Haicang District,
- City
- Xiamen City Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Austar Hearing Science & Technology (Xiamen) Co., Ltd.
- Operator Number
- 10033821
- Address
- Building B8, Biomedical Industrial Park,No.2064 Wengiiao West Road, Haicang District
- City
- Xiamen City
- State
- Fujian
- Postal Code
- 361022
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 2010-10-07 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-12-20 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-08-01 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2010-10-07 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2023-01-29 |
Proprietary Names
One-Fit-All In-The-Ear Hearing Aid (Faceplate Kits included)
In-The-Ear Hearing Aid (FD02A,HE07,DM04)
In-The-Ear Hearing Aid (Faceplate Kits included)
Digital Rechargeable RIC OTC Hearing Aids (FHE504,FHE503,FHE412,FHE411,FHE410,FHE409,FHE408,FHE407,FHE406,FHE405,FHE404,FHE403)
Digital Rechargeable RIC OTC Hearing Aids (FHE512,FHE511,FHE510,FHE509,FHE508,FHE507,FHE506,FHE505)
Digital Rechargeable ITE OTC Hearing Aids (F712A, F711A, F710A, F709A, F708A, F707A, F706A, F705A, F704A, F703A)
Digital Rechargeable ITE OTC Hearing Aids (F812C, F811C, F810C, F809C, F808C, F807C, F806C, F805C, F804C, F803C)
Behind-The-Ear Hearing Aid (Otofonix)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH412, FH411, FH410, FH409, FH408, FH407, FH406, FH405, FH404, FH403)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH812, FH811, FH810, FH809, FH808, FH807, FH806, FH805, FH804, FH803)
Digital Rechargeable ITE OTC Hearing Aids (F812A, F811A, F810A, F809A, F808A, F807A, F806A, F805A, F804A, F803A)
Air-Conduction Hearing Aid
Digital Rechargeable ITE OTC Hearing Aids (F812B, F811B, F810B, F809B, F808B, F807B, F806B, F805B, F804B, F803B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH212, FH211, FH210, FH209, FH208, FH207, FH206, FH205, FH204, FH203)
Rechargeable OTC Hearing Aids (ATOM ONE, ATOM 2, ATOM PRO2, FA915, FA916, FA816)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH312,HA300,FH311,FH310,FH309,FH308,FH307,FH306,FH305,FH304,FH303)
Digital Rechargeable RIC OTC Hearing Aids(FHE712, FHE711, FHE710, FHE709, FHE708, FHE707,FHE706, FHE705, FHE704, FHE703)
Digital Rechargeable RIC OTC Hearing Aids(FHE912, FHE911, FHE910, FHE909, FHE908, FHE907,FHE906, FHE905, FHE904,FHE903)
Rechargeable OTC Hearing Aids (ION)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH712, FH711, FH710, FH709, FH708, FH707,FH706, FH705, FH704, FH703)
Digital Rechargeable RIC OTC Hearing Aids(FHE212, FHE211, FHE210, FHE209, FHE208, FHE207,FHE206, FHE205, FHE204, FHE203)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH912, FH911, FH910, FH909, FH908, FH907,FH906, FH905, FH904, FH903)
Digital Rechargeable RIC OTC Hearing Aids(FHE612, FHE611, FHE610, FHE609, FHE608, FHE607, FHE606, FHE605, FHE604,FHE603)
OTC HEARING AIDS (ion2)
Digital Rechargeable RIC OTC Hearing Aids (FHE312,FHE311, FHE310, FHE309, FHE308, FHE307,FHE306, FHE305, FHE304, FHE303)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH612, FH611, FH610, FH609, FH608, FH607, FH606, FH605, FH604, FH603)
Digital Rechargeable RIC OTC Hearing Aids(FHE812, FHE811, FHE810, FHE809, FHE808, FHE807, FHE806, FHE805, FHE804,FHE803)
Digital Rechargeable ITE OTC Hearing Aids (F912A, F911A, F910A, F909A, F908A, F907A, F906A, F905A, F904A, F903A
Digital Rechargeable BTE-OE OTC Hearing Aids (FH512, FH511, FH510, FH509, FH508, FH507,FH506, FH505, FH504, FH503)
Digital Rechargeable ITE OTC Hearing Aids (F912C, F911C, F910C, F909C, F908C, F907C, F906C, F905C, F904C, F903C)
Digital Rechargeable ITE OTC Hearing Aids (F712B, F711B, F710B, F709B, F708B, F707B, F706B, F705B, F704B, F703B)
Digital Rechargeable ITE OTC Hearing Aids (F912B, F911B, F910B, F909B, F908B, F907B, F906B, F905B, F904B, F903B)
Digital Rechargeable ITE OTC Hearing Aids (F712C, F711C, F710C, F709C, F708C, F707C, F706C, F705C, F704C, F703C)
Nebroo hearing aid: F703A
Digital Rechargeable BTE-OE Hearing Aids (FH312-B, FH311-B, FH310-B, FH309-B, FH308-B, FH307-B, FH306-B, FH305-B, FH304-B, FH303-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE408-B, FHE407-B, FHE406-B, FHE405-B, FHE404-B, FHE403-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE512-B, FHE511-B, FHE510-B, FHE509-B, FHE508-B, FHE507-B, FHE506-B)
Digital Rechargeable BTE-OE Hearing Aids(FH912-B,FH911-B,FH910-B,FH909-B,FH908-B,FH907-B,FH906-B,FH905-B,FH904-B,FH903-B
Digital Rechargeable BTE-RIC Hearing Aids (FHE912-B, FHE911-B, FHE910-B, FHE909-B, FHE908-B)
Digital Rechargeable BTE-OE Hearing Aids(FH612-B,FH611-B,FH610-B,FH609-B,FH608-B,FH607-B,FH606-B,FH605-B,FH604-B,FH603-B
Digital Rechargeable BTE-RIC Hearing Aids (FHE812-B, FHE811-B, FHE810-B, FHE809-B, FHE808-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE207-B, FHE206-B, FHE205-B, FHE204-B, FHE203-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE612-B, FHE611-B, FHE610-B, FHE609-B, FHE608-B)
Digital Rechargeable BTE-OE Hearing Aids(FH712-B,FH711-B,FH710-B,FH709-B,FH708-B,FH707-B,FH706-B,FH705-B,FH704-B,FH703-B
Digital Rechargeable BTE-OE Hearing Aids(FH812-B,FH811-B,FH810-B,FH809-B,FH808-B,FH807-B,FH806-B,FH805-B,FH804-B,FH803-B
Digital Rechargeable BTE-OE Hearing Aids(FH412-B,FH411-B,FH410-B,FH409-B,FH408-B,FH407-B,FH406-B,FH405-B,FH404-B,FH403-B
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 (FHE712-B, FHE711-B, FHE710-B, FHE709-B, FHE708-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE505-B, FHE504-B, FHE503-B, FHE412-B, FHE411-B, FHE410-B, FHE409-B, )
In-The-Ear Hearing Aid with Ear Union APP
Digital Rechargeable BTE-OE Hearing Aids (FH212-B, FH211-B, FH210-B, FH209-B, FH208-B, FH207-B, FH206-B, FH205-B, FH204-B, FH203-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE707-B,FHE706-B, FHE705-B, FHE704-B, FHE703-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE907-B, FHE906-B, FHE905-B, FHE904-B, FHE903-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE807-B, FHE806-B, FHE805-B, FHE804-B, FHE803-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE312-B, FHE311-B, FHE310-B, FHE309-B, FHE308-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE307-B, FHE306-B, FHE305-B, FHE304-B, FHE303-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE212-B, FHE211-B, FHE210-B, FHE209-B, FHE208-B)
Digital Rechargeable BTE-RIC Hearing Aids (FHE607-B, FHE606-B, FHE605-B, FHE604-B, FHE603-B)
Behind-The-Ear Hearing Aid (B304,B304P,B304U,B305P,B305U,SU05U,SU05P)
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 (F712C, F711C, F710C, F709C, F708C, F707C, F706C, F705C, F704C, F703C)
Digital Rechargeable ITE Hearing Aids (F812A, F811A, F810A, F809A, F808A, F807A, F806A, F805A, F804A, F803A)
Digital Rechargeable BTE-OE Hearing Aids (FH612, FH611, FH610, FH609, FH608, FH607, FH606, FH605, FH604, FH603)
Digital Rechargeable RIC Hearing Aids (FHE912, FHE911, FHE910, FHE909, FHE908, FHE907,FHE906, FHE905, FHE904, FHE903)
Digital Rechargeable BTE-OE Hearing Aids (FH512, FH511, FH510, FH509, FH508, FH507,FH506, FH505, FH504, FH503)
Digital Rechargeable ITE Hearing Aids (F912B, F911B, F910B, F909B, F908B, F907B, F906B, F905B, F904B, F903B)
Digital Rechargeable RIC Hearing Aids (FHE212, FHE211, FHE210, FHE209, FHE208, FHE207,FHE206, FHE205, FHE204, FHE203)
Digital Rechargeable RIC Hearing Aids (FHE612, FHE611, FHE610, FHE609, FHE608, FHE607, FHE606, FHE605, FHE604, FHE603)
Digital Rechargeable BTE-OE Hearing Aids (FH812, FH811, FH810, FH809, FH808, FH807, FH806, FH805, FH804, FH803)
Digital Rechargeable BTE-OE Hearing Aids(FH312,FH311,FH310,FH309,FH308,FH307,FH306,FH305)
Digital Rechargeable RIC Hearing Aids (FHE512,FHE511,FHE510,FHE509,FHE508,FHE507,FHE506,FHE505,FHE504,FHE503)
Digital Rechargeable BTE-OE Hearing Aids (FH712, FH711, FH710, FH709, FH708, FH707,FH706, FH705, FH704, FH703)
Digital Rechargeable BTE-OE Hearing Aids (FH912, FH911, FH910, FH909, FH908, FH907,FH906, FH905, FH904, FH903)
Digital Rechargeable RIC Hearing Aids (FHE812, FHE811, FHE810, FHE809, FHE808, FHE807, FHE806, FHE805, FHE804, FHE803)
Digital Rechargeable ITE Hearing Aids (F712B, F711B, F710B, F709B, F708B, F707B, F706B, F705B, F704B, F703B)
Digital Rechargeable BTE-OE Hearing Aids (FH412, FH411, FH410, FH409, FH408, FH407, FH406, FH405, FH404, FH403)
Digital Rechargeable ITE Hearing Aids (F712A, F711A, F710A, F709A, F708A, F707A, F706A, F705A, F704A, F703A)
Digital Rechargeable ITE Hearing Aids (F812B, F811B, F810B, F809B, F808B, F807B, F806B, F805B, F804B, F803B)
Digital Rechargeable ITE Hearing Aids (F912A, F911A, F910A, F909A, F908A, F907A, F906A, F905A, F904A, F903A)
Digital Rechargeable ITE Hearing Aids (F812C, F811C, F810C, F809C, F808C, F807C, F806C, F805C, F804C, F803C)
Digital Rechargeable ITE Hearing Aids (F912C, F911C, F910C, F909C, F908C, F907C, F906C, F905C, F904C, F903C)
Digital Rechargeable RIC Hearing Aids (FHE312, FHE311, FHE310, FHE309, FHE308, FHE307,FHE306, FHE305, FHE304, FHE303)
Digital Rechargeable RIC Hearing Aids (FHE712, FHE711, FHE710, FHE709, FHE708, FHE707,FHE706, FHE705, FHE704, FHE703)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH312-B, FH311-B, FH310-B, FH309-B, FH308-B, FH307-B, FH306-B, FH305-B, FH304-B, FH303-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE 307-B, FHE306-B, FHE305-B, FHE304-B, FHE303-B)
Air-Conduction Hearing Aid with Wireless Technology and Ear Union APP
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE907-B, FHE906-B, FHE905-B, FHE904-B, FHE903-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH407-B, FH406-B, FH405-B FH404-B, FH403-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH412-B, FH411-B, FH410-B, FH409-B, FH408-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH707-B,FH706-B, FH705-B, FH704-B,FH703-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH507-B,FH506-B, FH505-B, FH504-B, FH503-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE212-B, FHE211-B, FHE210-B, FHE209-B, FHE208-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE912-B, FHE911-B, FHE910-B, FHE909-B, FHE908-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)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH607-B, FH606-B, FH605-B, FH604-B,FH603-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE505-B, FHE504-B, FHE503-B, FHE412-B, FHE411-B, FHE410-B, FHE409-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 (FH512-B, FH511-B, FH510-B, FH509-B, FH508-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE408-B, FHE407-B, FHE406-B, FHE405-B, FHE404-B, FHE403-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE512-B, FHE511-B, FHE510-B, FHE509-B, FHE508-B, FHE507-B, FHE506-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH907-B, FH906-B, FH905-B, FH904-B, FH903-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE 207-B, FHE206-B, FHE205-B, FHE204-B, FHE203-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH912-B, FH911-B, FH910-B,FH909-B, FH908-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH812-B,FH811-B,FH810-B, FH809-B,FH808-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH712-B, FH711-B, FH710-B, FH709-B, FH708-B)
Rechargeable OTC Hearing Aids (ATOM X, FAX816-B, FAX916-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE812-B, FHE811-B, FHE810-B, FHE809-B, FHE808-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE312-B, FHE311-B, FHE310-B, FHE309-B, FHE308-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE807-B, FHE806-B, FHE805-B, FHE804-B, FHE803-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE707-B,FHE706-B, FHE705-B, FHE704-B, FHE703-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH807-B,FH806-B,FH805-B FH804-B,FH803-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE607-B, FHE606-B, FHE605-B, FHE604-B, FHE603-B)
Digital Rechargeable BTE-RIC OTC Hearing Aids (FHE712-B, FHE711-B, FHE710-B, FHE709-B, FHE708-B)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH612-B, FH611-B, FH610-B, FH609-B, FH608-B)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device