OPRO mouthguards are certified as personal protective equipment (PPE) under EU Regulation 2016/425. Our Nightguard is a Class I medical device under the EU Medical Devices Regulation (EU) 2017/745, and our rechargeable cleaning products comply with the relevant EU legislation on electromagnetic compatibility, hazardous substances (RoHS) and batteries.

Below you can download the Declaration of Conformity for each product, along with the EU type-examination certificates issued by our notified body, SATRA Technology Europe Limited (Notified Body 2777). Select a box to download that document as a PDF.

If you need a document that isn't listed here, please contact our team.