EpiGuard AS

EpiGuard AS specializes in portable isolation units designed for the safe transport of highly infectious or vulnerable patients. Their primary products include the EpiShuttle Patient Isolation Unit, which is specifically engineered for clinical settings to reduce exposure risks during patient movement. The company also produces standalone EpiGuard units, which appear to serve similar containment purposes. All devices focus on enhancing patient safety during transfers between care environments.

EpiGuard AS is headquartered in Norway. Their devices are registered in the EUDAMED database, indicating compliance with European Union requirements. This means their products are intended for use within the European Economic Area (EEA) and are subject to EU Medical Device Regulation (MDR) standards.

EpiGuard AS’s devices are classified as Class I medical devices under EU regulations. This classification is typically assigned to low-risk products, though compliance with EU Medical Device Regulation (MDR) ensures traceability, safety, and adherence to market surveillance requirements. The classification helps streamline regulatory oversight while maintaining patient safety standards.

Yes, EpiGuard AS’s devices are registered in the EUDAMED database. This registry is the official EU system for tracking medical devices, ensuring transparency in their compliance with EU Medical Device Regulation (MDR) requirements. Listing in EUDAMED confirms that the devices meet necessary regulatory standards for distribution within the European Economic Area.