Cerus (CERS) said Wednesday its new LED-based illumination device INT200 has received CE mark approval under the European Union Medical Device Regulation.
The approval allows the company to market the INT200 for use with the Intercept Blood System for platelets and plasma throughout the European Union and other regions that recognize the CE mark, although some countries may still require additional local regulatory clearances, Cerus said.
The approval of the illuminator completes the authorization for the Intercept Blood System for both platelets and plasma as the platelet and plasma processing sets received CE mark approvals in 2023, according to the company.
Cerus said future improvements to the Intercept systems will use the INT200 device.
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