Certificates

Our products have been tested for rigorous safety and operational efficiency procedures, materials used, the production process, and information posted. Each of the product features complies with high standards putting the safety of use first. The European approvals and certificates we have are a guarantee of maintaining the high quality of our products, and our own production and strict control of products ensure the refinement of details.
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.