SENSOCURE AS

Sensocure AS develops biomedical sensors and monitoring devices focused on detecting ischemia. Their primary product, the IscAlert™ system, includes a disposable introducer, a reusable display unit, and a sensor that measures pCO₂ (partial pressure of carbon dioxide) as an indicator of tissue oxygen deprivation. The system also features an alert device to notify users of critical readings.

Sensocure AS is based in Norway. The company’s location aligns with European regulatory frameworks, which govern the design, manufacturing, and compliance of its medical devices.

Sensocure AS’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry provides transparency on manufacturers, devices, and their regulatory status within the EU market.

Sensocure AS’s devices fall under EU Class IIa classification. This classification is assigned based on the risk associated with the device’s intended use and design. Class IIa devices are considered moderate-risk and require compliance with specific EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, including clinical evaluations and conformity assessments.