Bulbitech Achieves MDR Class IIa Certification

Bulbitech has successfully obtained MDR Class IIa certification under the European Medical Device Regulation (MDR), marking a significant regulatory milestone for the company.

This certification enables us to provide our technology as a diagnostic support tool to healthcare providers across Europe. By delivering functional biomarkers that are not detectable through conventional clinical methods, our solution strengthens objective assessment in neurology and ophthalmology.

Achieving MDR Class IIa certification reflects the robustness of our clinical validation, quality management systems, and regulatory processes. It also underscores our commitment to meeting the highest European standards for safety, performance, and clinical benefit.

We extend our sincere gratitude to our clinical partners, research collaborators, and everyone who has contributed to this achievement. Their expertise and dedication have been instrumental throughout this journey.