In order to satisfy our Customers’ needs and to deliver superior quality products, we have implemented ISO quality systems, and we have been awarded ISO 9001:2008 and ISO 13485:2003 certificates.
Certificates
Bearing in mind safety and health of the Users, our products are compliant with European safety regulations and we are authorised to use the CE mark.
Certificate according to Medical Devices Derictive (MDD) 93/42/EEC
Pursuant to REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, we declare that our products, certified in accordance with Directive 93/42/EEC, may be placed on the market or put into service until 31 December 2028.
Certificate according to Quality Assurance System Directive 93/42/EEC
Pursuant to REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, we declare that our products, certified in accordance with Directive 93/42/EEC, may be placed on the market or put into service until 31 December 2028.