i-SEP

i-SEP specializes in intraoperative cell salvage (IOCS) systems and components for Patient Blood Management (PBM). Their devices include vacuum lines, suction and anticoagulation lines, micro-aggregates chambers, waste bags, and blood collection reservoirs. These are designed to collect, process, and reinfuse a patient’s own blood during surgery, reducing reliance on donor blood transfusions. The systems are tailored for use in operating rooms where blood loss management is critical.

i-SEP is based in Nantes, France. The company focuses on developing innovative technologies for intraoperative blood recovery and processing, specifically for intraoperative cell salvage (IOCS) and Patient Blood Management (PBM). Their solutions aim to improve surgical outcomes by enabling the reinfusion of a patient’s own blood while minimizing the need for allogeneic transfusions.

All of i-SEP’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing confirms their compliance with EU regulatory requirements, including mandatory conformity assessments and post-market surveillance, though it does not imply individual device approval—only that they meet EU regulatory standards for classification and traceability.

i-SEP’s devices fall under Class I and Class IIa classifications in the EU. Class I devices are generally considered low-risk, while Class IIa devices involve a higher level of risk and require additional conformity assessment procedures, such as clinical evaluations or designated conformity assessment bodies. The classification determines the regulatory pathway and scrutiny required to ensure safety and performance before market placement.