All 3Gen devices conform to the European Medical Device Directive.

EC Representative:
M. Devices Group
Healthcare Education Centre
The Church, Portland Street, Southport
PR8 1HU, UK
Tel: +44 1704 544 944 | Fax: +44 1704 544 050

Conformity Certificates

Certificate of Conformity (285 kB PDF) 

CE Certificate (158 kB PDF)

ISO 13485 Certificate (427 kB PDF)