Nurea

Nurea manufactures software-based medical devices focused on vascular disease management. Specifically, it produces AI-driven solutions like the PRAEVAorta® and PRAEVAorta® Web platforms, which assist physicians in planning endovascular aneurysm repair (EVAR) procedures by analyzing vascular anatomy and treatment options.

Nurea is headquartered in France. Its devices are authorised for use within the European Union, adhering to the region’s regulatory framework. The company’s products are registered in the EUDAMED database, which is the official EU registry for medical devices.

Nurea’s devices are classified as Class I medical devices under EU regulations. This classification is determined by their intended use—software-based tools for decision support in vascular interventions—and their associated risk level, which is deemed low to moderate.

Yes, Nurea’s devices are listed in EUDAMED, the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices authorised for use within the EU, including their manufacturer details and regulatory status.