Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003303986

FEI Number

3003303986

Entity Name

GN RESOUND CHINA, LTD.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

15 CHUANG XIN ROAD-CPA AREA, XIAMEN Fujian 361006, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GN Hearing A/S (Owner Number: 2182204)

Owner / Operator Contact Address

Lautrupbjerg 7, Ballerup, DK-84 2750, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tinnitus Sound Generator Module Generic Faceplate Enhance Plus Tinnitus Sound Generator Module Tinnitus Sound Generator Module Enhance Plus AGXR-E Vida OMNIA Smart Fit FM Receiver XB AGXR-XG Sentry Choice Dome LiNX Quattro ONE Enhance Max DAI Boot Vivia Enhance Pro 30 Celebrate Achieve Smart3D AGXR-XD Enhance Pro 10 First CS Smart Fit Forte MyPAL Pro DAI Shoe TV streamer+ AGXR-T Custom Charger Desktop Charger Cross Unit XE BeMore SureFit,transducer module with receiver in the ear XC Micro Mic LiNX TS BeMore Cala XH Aventa Imagine AGXR-L Commence Attune Legend Enzo 2 Lively Boost Max S Remote Control DAI ADAPTOR 3 Savi HearPlus Remote Control 2 Envision Rely Multi-Mic+ Audigy Acoustic Tubing Key Boost Plus XG Phone Clip Plus Up Enhance Pro PM SureFit,acoustic tubing Enhance Pro 20 Transducer module with receiver in the ear Discover Boost Ultra AGXR-N LiNX 3D Solus Pro Astro Pro Preza Relief Peak 7 AGXR-H ENZO Q Flyte AGXR-XB LiNX 2 Enzo IA Sport Lock Enzo 3D Wax Guard Peak Pro 9 Noahlink Verso Enzo Kirkland Signature 6 Phone Link 2 Enhance Select HearMax Multi Mic Premium Charger Nexia Amaze Up Smart Enya Serene Ear Mold AGXR-XH SureFit,domes SureFit,sport lock AGXR-XC LiNX Promise Boost Max Standard Charger Hearing Aid Battery Solus Max MyPAL Micro TV Link 2 AGXR-Q AGXR-XF Trust Enzo Core Ally Tuner Audigy 2 TV Streamer 2 Enhance Pro Smart AGXR-Y Tinnitus Sound Generator Module Tinnitus Sound Generator Module Tinnitus Sound Generator Module

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2019-02-27
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	1994-09-15
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-10-21
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2015-11-03
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2019-02-27
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-02-10
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2022-02-10
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2011-11-22
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2011-11-22
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2022-04-28
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2008-06-23

Official Correspondent

No official correspondent registered.

US Agent Details

Thomas Brockway Email: tbrockway@gn.com Phone: (952) 7698048

Related Public Records

Same Entity

GN Hearing A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005650109	GN Hearing A/S	BALLERUP Hovedstaden, DK
3026048380	GN ReSound (Malaysia) Sdn. Bhd	Senai Johor, MY
3011927597	GN ReSound (Malaysia) Sdn Bhd.	Kulai Johor, MY
2182204	GN Hearing Care Corporation	Shakopee, MN, US

Similar Registrations

Registration Number	Establishment Name	Location
3026390997	AURELIYM GMBH	Bad Neuenahr-Ahrweiler Rhineland-Palatinate, DE
3002808415	Unitron Hearing, a division of National Hearing Services Inc.	KITCHENER Ontario, CA
3005019184	Sivantos GmbH	Erlangen Bavaria, DE
3004929038	Sonova Hearing (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2182204	GN Hearing Care Corporation	Shakopee, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003303986. Last updated year: 2026. Please use registration number 3003303986 when referencing this establishment in official correspondence.