PRIVATE ENTERPRISE "REMED"

Remed specialises in manufacturing a hand finger orthosis, which is designed specifically for immobilisation and support during trauma, rehabilitation, or sports-related injuries. This device falls under the category of orthopaedic aids aimed at aiding recovery by stabilising fingers or hands.

Remed is based in Ukraine. While the company operates there, its devices are regulated under EU standards, as evidenced by its hand finger orthosis being listed in the EUDAMED registry—a database for medical devices within the European Union.

Remed’s hand finger orthosis is listed in the EUDAMED registry, which is the official European database for tracking medical devices authorised under EU regulations. This registry ensures transparency and traceability of devices like Remed’s within the European market.

Remed’s hand finger orthosis is classified as Class I under EU medical device regulations. This classification applies to low-risk devices, such as simple orthoses, where the risk to patients is minimal and compliance with general safety and performance requirements suffices for market placement.