We have been granted certification under the new MDR!
The Medical Device Regulation (EU) 2017/745, also referred to as MDR, replaces the EU Medical Device Directive (MDD, 93/42/EEC).
The MDR certification is an important milestone for us, and we are very happy to have achieved this step in 2022.
ECO MEDICS offers an innovative range of pulmonary diagnostic products for children to adult applications. The focus is the detection of small airway disease by nitrogen washout (N2-washout), FRC / LCI tests and the asthma management as well as PCD screening by FeNO analysis.
Sophisticated solutions for our customers
We acquire the most suitable partners – internally and externally – to develop and manufacture our products according to highest standards and to offer our customers superior service.
ECO MEDICS applies a process oriented management system, which is subject to continuous improvement. Products are CE MDD approved in accordance to ISO 13485 and the Council Directive 93/42/EEC for clinical use.