Declarations of Conformity & CE Certificates
Product compliance documents for OPRO mouthguards and cleaning products.
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.
Declarations of Conformity
Declaration of Conformity
Instant Custom-Fit Mouthguards
Covers all Instant Custom-Fit models and colours, including Instant Custom-Fit for braces. Category II PPE under EU Regulation 2016/425.
Declaration of Conformity
Self-Fit Mouthguards
Covers all Self-Fit models and colours, including Bronze, Silver, Gold, Gold Braces and Platinum. Category II PPE under EU Regulation 2016/425.
Declaration of Conformity
Snap-Fit Mouthguards
Covers all Snap-Fit models and colours, including Snap-Fit for braces. Category II PPE under EU Regulation 2016/425.
Declaration of Conformity
Custom-Fit Mouthguards
Covers all made-to-measure Custom-Fit models and colours. Category II PPE under EU Regulation 2016/425.
Declaration of Conformity
Nightguard
Class I medical device under the EU Medical Devices Regulation (EU) 2017/745.
Declaration of Conformity
UV Cleaning Case
Model OPR-003U. Complies with EU electromagnetic compatibility, RoHS and battery legislation.
Declaration of Conformity
Compact Ultrasonic UV Cleaner
Model US600. Complies with EU electromagnetic compatibility, RoHS and battery legislation.
EU Type-Examination Certificates
EU type-examination certificate
Instant Custom-Fit Mouthguards
Issued by SATRA Technology Europe Limited (Notified Body 2777) under Module B of EU Regulation 2016/425. Tested to SATRA M33:2022.
EU type-examination certificate
Self-Fit Mouthguards
Issued by SATRA Technology Europe Limited (Notified Body 2777) under Module B of EU Regulation 2016/425. Tested to SATRA M33:2022.
EU type-examination certificate
Snap-Fit Mouthguards
Issued by SATRA Technology Europe Limited (Notified Body 2777) under Module B of EU Regulation 2016/425. Tested to SATRA M33:2022.
EU type-examination certificate
Custom-Fit Mouthguards
Issued by SATRA Technology Europe Limited (Notified Body 2777) under Module B of EU Regulation 2016/425. Tested to SATRA M33:2022.