Committed to your patients' safety

At Theia Eye Block, our mission is simple. We want to be a partner in your success - by protecting the well-being of those you serve. To do that, we believe there in nothing more important than offering safe, economical, easy-to-use eye protection for your patients’ safety.

Manufacturing to a higher standard than the others

THEIA EYE BLOCK is the ONLY disposable eye shield company that manufactures to FDA Certified Class 1 Medical Device and European Union Medical Device regulations.

What does that mean? THEIA EYE BLOCK is the only one that manufactures to the much-higher national and international ‘Medical Device’ standards. These standards ensure your patient will benefit from the good manufacturing practices, higher quality and on-going safety compliance that these standards demand.

Class 1 Medical Device vs. PPE

• All products designed to be used / worn by patients are required to be Class 1 devices per Union harmonization legislation Regulation (EU) 2017/745 (MDR) and Directive 93/42/EEC
• PPE only tests certain features of a product. It does not address process, design or quality.
• Class 1 devices require a comprehensive Quality Management System ( QMS)
• QMS encompasses design, process, quality control, documentation and verification including fail mode analysis
  
  

Third Party Certified

All performance, safety, and manufacturing standards are certified by independent third parties.

Made in the USA

THEIA EYE BLOCK proudly manufactures disposable eye shields to the highest standards right here in the USA.