Adding more notes to the post:

== CE marking is an administrative marking with which the manufacturer or importer affirms its conformity with European health, safety, and environmental protection standards for products sold within the European Economic Area. It is not a –quality indicator or a certification mark–. Wikipedia

== CE marking indicates that a –product has been assessed by the manufacturer– and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

== The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health. The EMA is the European Union’s equivalent to the U.S. Food and Drug Administration (FDA).