Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008606477

FEI Number

3008606477

Entity Name

AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD

City/State/Country

Xiamen City Fujian, CN

Establishment 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,, Xiamen City Fujian 361022, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Austar Hearing Science & Technology (Xiamen) Co., Ltd. (Owner Number: 10033821)

Owner / Operator Contact Address

Building B8, Biomedical Industrial Park,No.2064 Wengiiao West Road, Haicang District, Xiamen City, CN-FJ 361022, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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) Behind-The-Ear Hearing Aid (Otofonix) 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	2010-10-07
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-12-20
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2022-08-01
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2010-10-07

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Austar Hearing Science & Technology (Xiamen) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008606477. Last updated year: 2026. Please use registration number 3008606477 when referencing this establishment in official correspondence.