Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010408889

FEI Number

3010408889

Entity Name

XIAMEN RETONE HEARING TECHNOLOGY CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

Room 209, 2nd floor, No. 999 Tianma Road, Jimei District, Xiamen Fujian 361000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Xiamen Retone Hearing Technology Co., Ltd. (Owner Number: 10044151)

Owner / Operator Contact Address

Room 209, 2nd floor, No. 999 Tianma Road, Jimei District, Xiamen, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Behind-The-Ear Hearing Aid In-The-Ear Hearing Aid K Series, Gio Series, Echo Series, Bright Series, Smart Series Bro Series, Eggo Series, Gio Series, K Series, Smart Series, Smart U Series, Vigor Series, Vigor U Series Echo Series, Atom, Atom Pro, Atom 2, Atom pro2, Atom One, Neo, Neo XS, HEARIZON K818SP-P, K218SP, K18S, Vigor 402BT-P, Vigor 402P Bright Series, Clear Series In-The-Ear Hearing Aid (Faceplate Kits Included) Behind-The-Ear Hearing Aid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2022-10-21
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-10-21
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2013-05-07
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2022-10-21

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

Xiamen Retone Hearing Technology 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 3010408889. Last updated year: 2026. Please use registration number 3010408889 when referencing this establishment in official correspondence.