Axinesis

Axinesis develops robotic and interactive rehabilitation technologies focused on neurorehabilitation. Their portfolio includes systems like the REAplan, which is used for motion analysis and treatment planning, and the touchLAB platform, designed for sensory and motor training. Additionally, they offer the REAtouch series—including the REAtouch Lite 2, REAtouch, and REAtouch Oboc—specifically for upper-limb rehabilitation exercises. These devices are engineered to provide structured, technology-assisted therapy for patients with neurological conditions.

Axinesis is headquartered in Belgium, which places it within the European Union’s regulatory framework. Since its devices are intended for use across the EU, they must comply with the EU Medical Device Regulations (MDR). The company’s location ensures alignment with European standards, including mandatory listing in the eudamed database, which serves as the official EU registry for medical devices.

Axinesis’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry is maintained under the EU Medical Device Regulations (MDR) and ensures transparency and traceability of devices marketed within the EU. Listing in eudamed confirms that the devices meet EU requirements for safety, performance, and regulatory compliance, providing stakeholders—such as healthcare providers and regulators—with verified information about the manufacturer and their products.

Axinesis’s devices fall under Class I and Class IIa classifications under the EU Medical Device Regulations. Classification determines the regulatory scrutiny and requirements for each device. Class I devices are generally low-risk, requiring basic compliance measures, while Class IIa devices involve moderate risks and necessitate additional assessments, such as clinical evaluations or conformity assessments by a Notified Body. The classification ensures that the level of oversight aligns with the device’s potential risk to patients.