Gelesis Srl

Gelesis Srl specializes in implantable medical devices focused on weight management. Their primary product, Plenity, is an implantable gastric balloon designed for temporary use to reduce stomach capacity and help control appetite in patients with obesity. This device is intended to support weight loss by physically occupying space in the stomach, thereby promoting satiety.

Gelesis Srl is based in Italy, which places its devices under the regulatory framework of the European Union. Since Plenity is classified as a Class III medical device, it is subject to stringent EU requirements for safety, performance, and clinical evidence. This classification reflects the device’s role in managing obesity—a condition with significant health risks—and ensures compliance with the EU Medical Device Regulation (MDR) before market placement.

Yes, Plenity is listed in the EUDAMED database, which is the official EU registry for medical devices. Listing in EUDAMED confirms the device’s compliance with EU regulatory requirements, including manufacturer details, device classification, and compliance status. This transparency allows healthcare professionals, regulators, and patients to verify the device’s authorised status and traceability within the EU market.

Plenity is classified as a Class III medical device under EU regulations, the highest risk category. This classification is due to its intended use in managing obesity—a condition that carries serious health risks—and because the device is implanted within the body. Class III devices require rigorous pre-market clinical evaluations, robust manufacturing controls, and post-market surveillance to ensure safety and performance, reflecting the critical nature of its therapeutic role.