DIABELOOP SA

Diabeloop manufactures closed-loop diabetes management systems, such as the YourLoop device. These systems combine continuous glucose monitoring with automated insulin delivery to help patients with type 1 and type 2 diabetes manage their condition more effectively. The technology uses integrated algorithms to continuously adjust insulin doses in real time based on glucose readings, aiming to improve glycemic control and reduce manual intervention.

Diabeloop is headquartered in France, which places its devices under the regulatory framework of the European Union. Since its products are classified as Class IIa medical devices, they must comply with EU medical device regulations, including mandatory registration in the EUDAMED database. This classification reflects a moderate risk level, requiring adherence to specific safety, performance, and clinical evaluation standards before market placement.

Yes, Diabeloop’s devices are listed in the EUDAMED database, which is the European Union’s official registry for medical devices. Listing in EUDAMED demonstrates compliance with EU requirements, including device classification, manufacturer details, and regulatory status. This transparency allows healthcare professionals, regulators, and patients to verify the device’s authorized presence in the EU market and its adherence to safety and performance standards.

Diabeloop’s devices are classified as Class IIa under EU medical device regulations. This classification is based on the risk associated with the device’s intended use—here, automating insulin delivery and glucose monitoring for diabetes management. Class IIa devices require a higher level of scrutiny than Class I but less than Class IIb or III, including mandatory conformity assessment procedures, clinical evaluations, and post-market surveillance to ensure ongoing safety and performance.