Data / Medical devices / Malaysia / GN ReSound (Malaysia) Sdn. Bhd
GN ReSound (Malaysia) Sdn. Bhd: FDA-registered device maker in Senai Johor, Malaysia, 1 510(k) clearance
GN ReSound (Malaysia) Sdn. Bhd is registered with the FDA (registration 3026048380) in Senai Johor, Malaysia. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 25, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3026048380
- Address
- No. 18, Jalan Kargo 2 Senai Airport City, Senai Johor, Malaysia, 81400
- Owner or operator
- GN Hearing A/S (2182204)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- May 31, 1989
- Registered through
- 2027
- Brand names listed
- AGXR-E, AGXR-H, AGXR-L, AGXR-N, AGXR-Q, AGXR-T, AGXR-XB, AGXR-XC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Plate Hearing Aid | LRB | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Prescription | QDD | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | QUH | Substantially Equivalent | GN Hearing A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Face Plate Hearing Aid
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- All makers of Self-Fitting Air-Conduction Hearing Aid, Prescription
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.