Committed to your patients' safety - at Theia Eye Block, their mission is simple. They want to be a partner in your success - by protecting the well-being of those you serve. To do that, they 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 US 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 in the USA.
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 in the USA.
