ACTIVEPURE MEDICAL LLC

ActivePure Medical LLC specializes in mobile high-efficiency filter air cleaners. These devices are designed to enhance indoor air quality in medical settings by removing airborne contaminants through advanced filtration and purification technologies. The primary example is the ActivePure Medical Guardian, which focuses on improving air cleanliness in healthcare environments.

ActivePure Medical LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance context, particularly for devices marketed in North America.

ActivePure Medical LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

ActivePure Medical LLC’s devices fall under FDA Class II classification. This classification is assigned based on the risk associated with the device—Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.