Nyxoah S.A.
Country not established
- Devices
- 1
What Nyxoah S.A. makes
Nyxoah S.A. manufactures the Genio® System 2.1, a medical device designed for the treatment of severe obstructive sleep apnea (OSA) in patients who cannot use continuous positive airway pressure (CPAP) therapy. The system includes a custom-fitted oral appliance that repositions the jaw to maintain an open airway during sleep.
The Genio® System 2.1 is classified as a Class III device under FDA regulations and is authorised through a Premarket Approval (PMA) application. The company is based in the United States.
Catalogue
Genio® System 2.1 Ref P240024
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Nyxoah S.A. have in the registry?
The registry currently lists 1 device for Nyxoah S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nyxoah S.A.'s devices?
Among its 1 most recently registered device, Nyxoah S.A. has devices listed in FDA PMA (1 device).
What risk classes do Nyxoah S.A.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Nyxoah S.A.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Nyxoah S.A. in the registry?
The most recently registered devices listed for Nyxoah S.A. include Genio® System 2.1.