Virtus Technology ApS

Virtus Technology ApS specializes in metabolic monitoring systems and flow sensors for adult patients. Their devices include standalone metabolic monitors and versions integrated with extracorporeal membrane oxygenation (ECMO) systems. These products measure critical physiological parameters like oxygen consumption, carbon dioxide production, and ventilation efficiency, primarily for use in intensive care environments.

Virtus Technology ApS is headquartered in Denmark, as indicated in their regulatory documentation. The company’s location is relevant for understanding its operational and compliance context under both EU and international medical device regulations.

Virtus Technology ApS’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices, and the FDA’s 510(k) registry in the United States. These listings reflect their compliance with regulatory requirements in both regions, ensuring transparency for healthcare providers and authorities.

Under the EU Medical Device Regulations, Virtus Technology ApS’s devices are classified as either Class I or Class II. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient. Class II devices typically involve a higher risk and require additional scrutiny, while Class I devices pose minimal risk. This classification determines the regulatory pathway and compliance obligations for each product.