Description
Certificates and standards
- Medical product according to standard EN:14683:2019+AC:2019
- MDR (UE) 2017/745
- Has European Intertek tests and CE declarations of conformity
- REACH (UE) 1907/2006
- Medical product was manufactured according to standards: ISO 9001 i ISO 13485
- EN 1041:2008+A1:2013
- EN ISO 14971:2012
- EN ISO 15223-1:2016
- EN ISO 10993-1:2009+AC:2010
- EN 62366-1:2015
