EUROSETS SRL

EuroSets SRL specializes in extracorporeal membrane oxygenators (ECMOs), which are devices used to support oxygenation and circulation outside the body. Their portfolio includes pediatric and infant-specific variants, such as the A.M.G.PMP PEDIATRIC and AMG PMP INFANT STERILE, as well as desk-mounted holders like the HOLDER. These products are designed for use in extracorporeal life support systems.

EuroSets SRL is based in the United States. As a manufacturer, it develops devices that must comply with applicable U.S. regulatory standards, including those governing extracorporeal membrane oxygenators and related accessories. While the company itself is not approved, its devices undergo individual regulatory processes to ensure compliance with safety and performance requirements.

EuroSets SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I and Class II devices, including their extracorporeal membrane oxygenators and holders, by assigning a unique identifier to each product.

EuroSets SRL’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may have fewer regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it, such as in extracorporeal life support systems.