Examples of CE Mark in a sentence
Regulatory StatusThe Reducer is approved for sale in Europe, having received CE Mark designation in November 2011.
Similarly, in the European Union, an in vitro companion diagnostic may be placed on the market only if it conforms to certain “essential requirements” and bears the Conformité Européene Mark, or CE Mark.
This product received regulatory clearance by the FDA in July 2013 and got its CE Mark for the European Union in August 2013.
Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019.
The conformity assessment process to obtain the CE Mark can be lengthy and we may fail to demonstrate such conformity.