SENSIUM HEALTHCARE LIMITED

Sensium Healthcare Limited specializes in nurse call systems, which are designed to facilitate communication between patients and healthcare staff. Their primary focus is on devices that improve patient monitoring and care coordination in healthcare environments, such as the Sensium Vitals system.

Sensium Healthcare Limited is headquartered in the United States. This location influences its regulatory compliance and market focus, particularly in the U.S. healthcare system.

Sensium Healthcare Limited’s devices, including nurse call systems like the Sensium Vitals, are classified as FDA Class II by the U.S. Food and Drug Administration. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, Sensium Healthcare Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices through standardized identifiers, ensuring transparency in the supply chain and aiding in post-market surveillance.