Our products comply with the following standards:
- PN EN 14683:2019+AC
- PN EN 1041:2013
- PN EN ISO 13485:2016
- PN EN ISO 15223-1:2017
- PN EN ISO 14971:2012
- PN EN ISO 10993-1:2010
and have the international CE declaration of conformity.
The products comply with the essential requirements of Annex I to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amendment of Directive 2001/83 /EC, Regulation (EC) No 178/2002 and Regulation (EC) No. 1223/2009 and the repeal of Council Directives 90/385/EEC and 93/42/EEC and the essential requirements of the Regulation of the Minister of Health of February 17, 2016 on essential requirements and conformity assessment procedures for medical devices.