What sets THEIA EYE BLOCK apart from the competition?

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 the 'Medical Device' standard mean?

It means that manufacturers must meet 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.

What is the difference between the Class 1 Medical Device vs. the PPE standard?

• 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

What is your return policy?
Product should be returned to your place of purchase and are subject to the return policy of the distributor.

​Do you ship overseas and to P.O. boxes?
Yes we do! Please email us at sales@theiaeye.com and we will assist you. 

​Do you have customer service?
Of course! Our friendly and knowledgeable customer services reps are available via email at sales@theiaeye.com.