Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026048380

FEI Number

3026048380

Entity Name

GN ReSound (Malaysia) Sdn. Bhd

City/State/Country

Senai Johor, MY

Establishment Address

No. 18, Jalan Kargo 2, Senai Airport City, Senai Johor 81400, MY

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,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

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 Enhance Plus Generic Faceplate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	1989-05-31
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-10-21
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	1994-09-15

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
3011927597	GN ReSound (Malaysia) Sdn Bhd.	Kulai 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

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026048380. Last updated year: 2026. Please use registration number 3026048380 when referencing this establishment in official correspondence.