GM501 Gradients CE marking according to new MDR

Valued customer,

We are very pleased to announce that GM501 Gradient 45%/ 90%/ 100% is now  CE-marked in conformity with the new European Medical Device Regulation (MDR, 2014/745.

CE marking of the product according to the MDR does result in the following changes:

If additional information or additional registration actions in your jurisdiction(s) are required, please send your question to