Data / Medical devices / Belgium / Nyxoah SA

Nyxoah SA: FDA-registered device maker in Mont-Saint-Guibert Brabant Wallon, Belgium, 1 PMA approval

Nyxoah SA is registered with the FDA (registration 3017191859) in Mont-Saint-Guibert Brabant Wallon, Belgium. 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

3017191859

Address

Rue Edouard Belin 12, Mont-Saint-Guibert Brabant Wallon, Belgium, 1435

Owner or operator

Nyxoah SA Mont Saint Guibert (10093936)

Roles

Manufacturer

First device listed

August 13, 2025

Registered through

2026

Brand names listed

Genio

Devices it lists

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

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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.