SurgiBox Secures CE Mark Approval for SurgiField™ System under European MDR

SurgiBox, a medical technology company focused on expanding access to safe surgery, has received CE Mark certification under the European Union’s Medical Device Regulation (MDR 2017/745) for its flagship SurgiField™ System.

The approval covers the SurgiBubble™, the sterile disposable component of the SurgiField™ platform, which integrates environmental control and personal protective equipment into an ultraportable surgical solution. 

With the electronic filtration system already approved, the complete SurgiField System is now cleared for commercial deployment across Europe and other international markets. 

The SurgiField System is the first ultraportable surgical environment designed to protect both patients and surgical teams from cross-contamination during procedures. The device is applied directly to the surgical site using standard draping methods. 

Once activated, the battery-powered Smart Control Module delivers operating room-grade HEPA-filtered airflow through a lightweight pop-up frame. Surgeons operate via integrated sleeve ports, allowing procedures to be performed with sterility in virtually any setting.
 
Preclinical studies and usability testing demonstrated the system’s effectiveness in isolating surgical sites and compatibility with diverse clinical workflows.

With CE Mark approval secured, SurgiBox is scaling its operations to meet growing demand. 
The company is expanding its supply chain, strengthening distribution networks, and launching a fundraising campaign to accelerate global adoption of the SurgiField System.