Everything that is legal
Our products are certified for more than 100 countries, including all countries of the European Union, as well as the USA, Canada, Brazil, Australia, Japan and Taiwan.
Legal responsibility for medical devices in the European Union is governed by the Medical Device Regulation (MDR). The specifications of the member states determine which authorities are responsible and which languages are required for certain documents. In Germany, the Medical Devices Implementation Act (MPDG) applies.
In 2020, detax was one of the first companies in the industry to receive full MDR certification.
Certificates for download
You can download our MDR certificates and other documents here.
Instruction for use AUDIO
Instruction for use DENTAL
Contact for questions and comments
Regulatory Affairs
regulatory.affairs@detax.de
Phone +49 7243 - 510-243