Onera B.V.

Onera B.V. specializes in polysomnography analysers, which are medical devices used to monitor and analyse sleep-related physiological data. These systems record parameters like brain activity, eye movements, muscle activity, heart rate, and breathing patterns during sleep studies, helping healthcare providers diagnose sleep disorders.

Onera B.V. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since its products are classified as Class II devices, they are subject to FDA regulations requiring premarket notification (510(k)) and unique device identification (UDI) compliance.

Onera B.V.’s devices are listed in the FDA’s 510(k) and UDI databases. The 510(k) registry demonstrates that each device has undergone a premarket notification process to show substantial equivalence to a legally marketed predicate device, while the UDI database ensures traceability and transparency in the supply chain for healthcare providers and regulators.

Onera B.V.’s polysomnography analysers are classified as Class II medical devices by the FDA. This classification indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. The classification influences the regulatory pathway, including mandatory compliance with 510(k) submissions and UDI requirements.