Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011927597

FEI Number

3011927597

Entity Name

GN ReSound (Malaysia) Sdn Bhd.

City/State/Country

Kulai Johor, MY

Establishment Address

No. 5, Jalan i-Park 1/1, Kawasan Perindustrian i-Park, Kulai Johor 81000, MY

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

Enhance Select 500 SureFit,sport lock Multi Mic Enhance Select 700 Enhance Select 200 Enhance Select 50R TV Streamer 2 Enhance Select 300 Phone Clip Plus Enhance Select 100 Enhance Select 50 Enhance Plus Tinnitus Sound Generator Module Tinnitus Sound Generator Module 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 Enhance Plus Tinnitus Sound Generator Module Hearing Aid Battery DAI ADAPTOR 2 XE BeMore Enhance Pro 20 SureFit,sport lock Key Forte Savi Origin AGXR-XB Peak Pro 9 Serene Legend Magna AGXR-Y Promise Enya Bold LiNX 3D Ally Solus Pro Transducer module with receiver in the ear Vida OMNIA Imagine Achieve Smart Fit Ear Mold Solus Max AGXR-L Cala Trust Dome Lex 800-M Lex 400-M AGXR-T SureFit,acoustic tubing SureFit,transducer module with receiver in the ear Enhance Pro 10 Wax Guard Verso SureFit,domes ONE Commence SureFit CROS/BICROS Vea Rely Flyte LiNX 2 Nexia Peak 7 Celebrate CS Smart Fit Sport Lock AGXR-XD Sentry Aventa AGXR-XF Tinnitus Sound Generator Module Tinnitus Sound Generator Module

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	2023-04-11
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
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
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2011-11-22
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	2019-02-27
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	1989-05-31
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2011-11-22
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2008-06-23

Official Correspondent

Pernille Bartel

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
3003303986	GN RESOUND CHINA, LTD.	XIAMEN Fujian, CN
2182204	GN Hearing Care Corporation	Shakopee, MN, US

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 3011927597. Last updated year: 2026. Please use registration number 3011927597 when referencing this establishment in official correspondence.