Efferon OÜ

Efferon OÜ specialises in hemoadsorption devices, specifically designed to remove endotoxins and inflammatory mediators directly from the bloodstream. These devices are intended for use in treating adults and pediatric patients with sepsis, septic shock, and cytokine release syndrome. The technology works by filtering harmful substances during extracorporeal circulation, ensuring single-use applications in critical care environments.

Efferon OÜ is headquartered in Estonia. Its devices are registered in the EUDAMED database, which is the European Union’s transparency system for medical devices. The company’s products fall under the EU Medical Device Regulation (MDR) and are classified as Class IIb, indicating a moderate-to-high risk level requiring compliance with stringent regulatory requirements.

Yes, Efferon OÜ’s devices are listed in the eudamed registry, which is the official EU database for medical device information. This listing ensures transparency and allows healthcare professionals, regulators, and patients to verify the device’s existence, classification, and regulatory status. Listing in eudamed is mandatory under the EU MDR for all medical devices placed on the market in the EU.

Efferon OÜ’s hemoadsorption devices are classified as Class IIb under the EU MDR. This classification is assigned based on factors like the device’s intended purpose, potential risks, and the severity of conditions it addresses. Class IIb devices pose moderate-to-high risks and require additional scrutiny, including clinical evaluations and conformity assessments, to ensure safety and performance before authorisation.