Data / Medical devices / United States / Nyxoah Inc
Nyxoah Inc: FDA-registered device maker in Summit, NJ, United States, 1 PMA approval
Nyxoah Inc is registered with the FDA (registration 3030384402) in Summit, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated August 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030384402
- Address
- 350 Springfield Ave Ste 200, Summit, NJ, United States, 07901
- Owner or operator
- Nyxoah SA Mont Saint Guibert (10093936)
- Roles
- Complaint file establishment
- First device listed
- August 13, 2025
- Registered through
- 2026
- Brand names listed
- Genio
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Hypoglossal Nerve, Implanted, Apnea | MNQ | 3 | Complaint file establishment | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 8, 2025 | P240024 | Genio® System 2.1 | MNQ | 4 | July 30, 2026 | accessdata.fda.gov |
Compare with other makers
Updated July 30, 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.