Compliance

BTE is a medical device manufacturer that provides therapeutic and rehabilitation systems for clinics, hospitals, and private practices. Compliance information is provided below.

General Compliance Documents

 

US FDA

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: EmergoVigilance@ul.com
Email for other communication: EmergoEurope@ul.com

 

EU Declaration of Conformity

 

EU Product Certificate

Eccentron EU Product Certificate

 

Disclaimers

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

RoHS

For RoHS information, visit the RoHS Compliance page.