Regulatory information

Regulatory information

Components of the LiMAx system (LiMAx FLIP detection device and breathing masks only) are CE marked as class IIa medical devices. The technology also includes LiMAxetin solution for injection, a pharmaceutical diagnostic drug licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for use as a 4 mg/ml solution for injection, administered by an intravenous bolus injection at a standard dose of 2 mg/kg.