Advice
Regulatory information
Regulatory information
CytoSorb was CE marked as a class IIb device in March 2011. It is made by CytoSorbents USA and distributed in the UK by Linc Medical.
The Medicines and Healthcare Products Regulatory Agency issued 1 manufacturer Field Safety Notice in 2015, containing advice about a potential incompatibility between the device and nitrous oxide, an inhaled anaesthetic gas. It states that CytoSorb should not be used in combination with nitrous oxide under any circumstances. No Medical Device Alerts were found for this device.