NOVAIR is the first French manufacturer of medical oxygen generators to obtain CE MDR certification (Medical Device Regulation (EU) 2017/745).

We are proud to be among the first companies in the world to receive this certification, which guarantees that our medical devices meet the safety and clinical benefit requirements set out in the highly demanding European regulations.

The Premium RX medical oxygen generator is the first generator made in France to obtain CE MDR certification, among the long list of NOVAIR solutions already covered by MDD certification.

All our teams, particularly the Quality & Regulatory Affairs and Engineering/Design Departments, worked together for over a year to achieve the high level of quality required by the DNV certification.

This crucial step for NOVAIR confirms the superior quality of its medical devices. We are delighted to be able to offer these certified devices to our demanding customers.