XENIOS AG

Xenios AG specializes in components for cardiopulmonary bypass systems, including blood tubing sets and centrifugal pump drive units. These devices are primarily used during open-heart surgeries or procedures requiring temporary circulatory support, such as the Novalung System, which provides extracorporeal life support for patients with severe heart or lung failure.

Xenios AG is based in the United States. While the company’s headquarters are in the US, its devices are designed and intended for use in the US market, adhering to applicable regulatory standards, including FDA compliance.

Xenios AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices under FDA oversight, particularly for Class II devices like those manufactured by Xenios.

Xenios AG’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as those used in cardiopulmonary bypass systems or extracorporeal life support.