ORTHOPUS

Orthopus specializes in robotic arm supports designed to improve upper-limb mobility for users aged seven to seventy-seven. These devices are intended to assist with arm movement and help users regain functional independence in daily activities, such as tasks requiring precision or strength. The product line includes a primary robotic arm system and an additional supportive accessory called the 'Orthopus supporter'.

Orthopus is based in France. As a manufacturer of medical devices, it operates under the European Union’s regulatory framework, ensuring compliance with EU medical device regulations. This includes adhering to requirements for assistive mobility aids, which govern design, manufacturing, and post-market surveillance.

Yes, Orthopus devices are registered in the EUDAMED database, which is the official European Union database for medical devices. Registration in EUDAMED is mandatory for manufacturers to demonstrate compliance with EU medical device regulations and to provide transparency on device availability and regulatory status.

Orthopus devices are classified as Class I medical devices in the EU. This classification is determined based on their intended purpose and risk level. Class I devices are generally considered low-risk, but they still require compliance with essential requirements to ensure safety and performance, such as proper design controls, manufacturing practices, and post-market monitoring.