The CE Mark under the European Union’s Medical Device Regulation (MDR 2017/745) standards certifies compliance with stringent health, safety, and environmental protection standards required for medical devices in the European Union. SurgiBox received CE Mark approval today for the SurgiBubble, the sterile device component of its SurgiField System, an ultraportable technology platform integrating intraprocedural environmental control and personal protective equipment. Combined with the previously approved electronic filtration system, the complete SurgiField System is now ready for market deployment.

This milestone, spearheaded by SurgiBox co-founder Sashidhar Jonnalagedda and CTO Atif Rakin, marks the successful certification of conformity with the EU’s Medical Device Regulation (MDR 2017/745) and ISO 13485:2016 standards – paving the way for commercial distribution across Europe and other key international markets.