To assist with anyone wanting to know the difference between CE mark and FDA approval/clearance.
https://crstodayeurope.com/articles/2015-feb/ce-mark-versus-fda-approval-which-system-has-it-right/
The first sentence reads: The CE Mark in the European Union and the FDA-approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new devices.
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- Ann: CE Marking received for core European product
Ann: CE Marking received for core European product, page-60
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