Biosurgical S.L

Biosurgical S.L specialises in medical devices primarily used in surgical and oncology procedures. Their portfolio includes temperature probe connection cables and systems specifically designed for hyperthermic intraperitoneal chemotherapy (HIPEC), such as the Combat PRS+ HIPEC and its associated system components. These devices are engineered to ensure precise temperature monitoring and control during HIPEC treatments.

Biosurgical S.L is based in Spain. The company’s devices are developed and marketed in compliance with EU medical device regulations, which govern safety, performance, and conformity assessment requirements for devices placed on the European market.

Biosurgical S.L’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This platform ensures transparency and traceability of devices authorised under EU regulatory frameworks, including those classified as Class IIa and Class IIb.

Biosurgical S.L’s devices are classified as Class IIa and Class IIb under the EU Medical Device Regulations. This classification is determined based on factors like the intended purpose, risk associated with use, and potential impact on patient safety. Class IIa devices pose a moderate risk, while Class IIb devices carry a higher risk, requiring additional scrutiny and conformity assessment procedures.