BAYOOCARE has received the MDR certificate for the class IIb medical device NeoDoppler in accordance with EU Regulation 2017/745. BAYOOCARE was certified by the notified body TÜV Süd.
This means that we are the holder of one of only around 1200 MDR product certificates in Europe to date. The cooperative team needed just 3 years to realise the project – from prototype to approval.
Thus, the class IIb medical device has now mastered another milestone on the way to final market launch. The NeoDoppler makes it possible to monitor the blood flow in the brain of premature or critically ill infants.
The cooperation was realised by BAYOOCARE GmbH (legal manufacturer), BAYOOMED GmbH (manufacturer of the software) Cimon Medical AS (copyright holder and spin-off of NTNU), Norbit (sample manufacturer), Aurotech AS (manufacturer of the ultrasound device), Bytech GmbH (manufacturing) and Mecora GmbH (packaging).