NOVAIR is the first French manufacturer of medical oxygen generators to obtain the CE MDR certificate (EU Medical Device Regulation 2017/745)
We are proud to be among the first companies in the world to receive this certificate, which guarantees that our medical devices meet the expectations of safety and clinical benefit set out in the demanding European regulations.
The Premium RX medical oxygen generator becomes the first Made in France generator to obtain the CE MDR certificate among the long list of NOVAIR solutions already covered by the MDD certification.
All our teams, in particular the Quality & Regulatory Affairs and the Engineering Departments, have worked together for more than a year to reach the high level of quality required by the certificate issued by DNV.
This crucial step for NOVAIR confirms the superior quality of its medical devices. We look forward to providing these certified devices to our demanding customers.