FDA Registration
Active
🇨🇳 China
Digital Rechargeable BTE-OE OTC Hearing Aids (FH912, FH911, FH910, FH909, FH908, FH907,FH906, FH905, FH904, FH903)
Reg #: 3008606477
·
FEI: 3008606477
·
Expires 2025
Products
1
Proprietary Names
30
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD
- Registration Number
- 3008606477
- FEI Number
- 3008606477
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-12-20 |
Proprietary Names
Digital Rechargeable BTE-OE OTC Hearing Aids (FH912, FH911, FH910, FH909, FH908, FH907,FH906, FH905, FH904, FH903)
Digital Rechargeable RIC OTC Hearing Aids(FHE812, FHE811, FHE810, FHE809, FHE808, FHE807, FHE806, FHE805, FHE804,FHE803)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH312,HA300,FH311,FH310,FH309,FH308,FH307,FH306,FH305,FH304,FH303)
Digital Rechargeable ITE OTC Hearing Aids (F812B, F811B, F810B, F809B, F808B, F807B, F806B, F805B, F804B, F803B)
Digital Rechargeable ITE OTC Hearing Aids (F912B, F911B, F910B, F909B, F908B, F907B, F906B, F905B, F904B, F903B)
Digital Rechargeable ITE OTC Hearing Aids (F712B, F711B, F710B, F709B, F708B, F707B, F706B, F705B, F704B, F703B)
Rechargeable OTC Hearing Aids (ION)
Digital Rechargeable ITE OTC Hearing Aids (F912A, F911A, F910A, F909A, F908A, F907A, F906A, F905A, F904A, F903A
Digital Rechargeable ITE OTC Hearing Aids (F912C, F911C, F910C, F909C, F908C, F907C, F906C, F905C, F904C, F903C)
Rechargeable OTC Hearing Aids (ATOM ONE, ATOM 2, ATOM PRO2, FA915, FA916, FA816)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH412, FH411, FH410, FH409, FH408, FH407, FH406, FH405, FH404, FH403)
Digital Rechargeable RIC OTC Hearing Aids(FHE912, FHE911, FHE910, FHE909, FHE908, FHE907,FHE906, FHE905, FHE904,FHE903)
Digital Rechargeable ITE OTC Hearing Aids (F712A, F711A, F710A, F709A, F708A, F707A, F706A, F705A, F704A, F703A)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH612, FH611, FH610, FH609, FH608, FH607, FH606, FH605, FH604, FH603)
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 RIC OTC Hearing Aids(FHE712, FHE711, FHE710, FHE709, FHE708, FHE707,FHE706, FHE705, FHE704, FHE703)
Digital Rechargeable ITE OTC Hearing Aids (F812A, F811A, F810A, F809A, F808A, F807A, F806A, F805A, F804A, F803A)
Digital Rechargeable ITE OTC Hearing Aids (F812C, F811C, F810C, F809C, F808C, F807C, F806C, F805C, F804C, F803C)
Behind-The-Ear Hearing Aid (Otofonix)
Digital Rechargeable RIC OTC Hearing Aids(FHE212, FHE211, FHE210, FHE209, FHE208, FHE207,FHE206, FHE205, FHE204, FHE203)
Digital Rechargeable ITE OTC Hearing Aids (F712C, F711C, F710C, F709C, F708C, F707C, F706C, F705C, F704C, F703C)
Digital Rechargeable RIC OTC Hearing Aids(FHE312, FHE311, FHE310, FHE309, FHE308, FHE307,FHE306, FHE305, FHE304, FHE303)
Digital Rechargeable RIC OTC Hearing Aids(FHE612, FHE611, FHE610, FHE609, FHE608, FHE607, FHE606, FHE605, FHE604,FHE603)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH512, FH511, FH510, FH509, FH508, FH507,FH506, FH505, FH504, FH503)
Air-Conduction Hearing Aid
Digital Rechargeable BTE-OE OTC Hearing Aids (FH212, FH211, FH210, FH209, FH208, FH207, FH206, FH205, FH204, FH203)
Nebroo hearing aid: F703A
Digital Rechargeable BTE-OE OTC Hearing Aids (FH712, FH711, FH710, FH709, FH708, FH707,FH706, FH705, FH704, FH703)
Digital Rechargeable BTE-OE OTC Hearing Aids (FH812, FH811, FH810, FH809, FH808, FH807, FH806, FH805, FH804, FH803)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device