Biotechmed S.r.l.

Biotechmed S.r.l. specialises in telemedicine systems, specifically the THOLOMEUS system. This device is designed for continuous remote health monitoring, enabling patients to be tracked by healthcare providers without needing in-person visits.

Biotechmed S.r.l. is based in Italy, which means its devices must comply with EU Medical Device Regulations. The THOLOMEUS system is registered in the EU via the eudamed database, demonstrating its adherence to EU regulatory requirements.

Biotechmed S.r.l.’s devices, including the THOLOMEUS system, are listed in the eudamed database. This registry is crucial because it provides transparency on EU-registered medical devices, allowing healthcare professionals, regulators, and patients to verify compliance with EU Medical Device Regulations.

The THOLOMEUS system is classified as a Class IIa medical device under EU regulations. This classification indicates a moderate risk level, requiring compliance with stricter design controls, clinical evaluations, and post-market surveillance compared to lower-risk devices. The classification ensures that the device meets safety and performance standards before entering the market.