BEUDAMED
    FDA Registration Active 🇨🇳 China

    In-The-Ear Hearing Aid with Ear Union APP

    Reg #: 3008606477 · FEI: 3008606477 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    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
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM

    Proprietary Names

    In-The-Ear Hearing Aid with Ear Union APP Digital Rechargeable BTE-RIC Hearing Aids (FHE408-B, FHE407-B, FHE406-B, FHE405-B, FHE404-B, FHE403-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(FH412-B,FH411-B,FH410-B,FH409-B,FH408-B,FH407-B,FH406-B,FH405-B,FH404-B,FH403-B Digital Rechargeable BTE-RIC Hearing Aids (FHE707-B,FHE706-B, FHE705-B, FHE704-B, FHE703-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE712-B, FHE711-B, FHE710-B, FHE709-B, FHE708-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE307-B, FHE306-B, FHE305-B, FHE304-B, FHE303-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE607-B, FHE606-B, FHE605-B, FHE604-B, FHE603-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE907-B, FHE906-B, FHE905-B, FHE904-B, FHE903-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-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-RIC Hearing Aids (FHE812-B, FHE811-B, FHE810-B, FHE809-B, FHE808-B) 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 (FHE312-B, FHE311-B, FHE310-B, FHE309-B, FHE308-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE612-B, FHE611-B, FHE610-B, FHE609-B, FHE608-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-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 (FHE505-B, FHE504-B, FHE503-B, FHE412-B, FHE411-B, FHE410-B, FHE409-B, ) Digital Rechargeable BTE-RIC Hearing Aids (FHE512-B, FHE511-B, FHE510-B, FHE509-B, FHE508-B, FHE507-B, FHE506-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE212-B, FHE211-B, FHE210-B, FHE209-B, FHE208-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE207-B, FHE206-B, FHE205-B, FHE204-B, FHE203-B) Digital Rechargeable BTE-RIC Hearing Aids (FHE807-B, FHE806-B, FHE805-B, FHE804-B, FHE803-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)

    Establishment Types

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