General Compliance Documents



The US FDA does not provide a certificate for Establishment or Device Registration and requires interested parties to go to the US FDA website for that information.


EU Authorized Representative

Emergo Europe
Authorized Representative in Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
Telephone: +31.70.345.8570
Email for vigilance reporting:
Email for other communication:


EU Declaration of Conformity


EU Product Certificate

Eccentron EU Product Certificate



Not all products are available in all markets.  Contact BTE if you have any compliance questions.


For RoHS information, visit the RoHS Compliance page.