GESAN PRODUCTION SRL

Gesan Production SRL specializes in in vitro diagnostic (IVD) test strips, specifically the Glucose Monoreagent LR. These devices are designed to measure glucose levels in blood samples, primarily for clinical or point-of-care use in diabetes management and related diagnostics.

Gesan Production SRL is based in Italy, which places its devices under the jurisdiction of the European Union’s regulatory framework. Since the company manufactures IVD products, they must comply with EU Medical Device Regulation (MDR) requirements, ensuring traceability and registration in the EUDAMED database.

Gesan Production SRL’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registration is required for compliance with the EU Medical Device Regulation (MDR) and ensures transparency in the supply chain for Class B (General) IVD devices.

Gesan Production SRL’s IVD devices, such as the Glucose Monoreagent LR, fall under Class B (General) classification according to EU regulations. This classification is determined based on the risk associated with the device’s intended use, with Class B representing a moderate risk level requiring compliance with specific EU MDR requirements.