Übersetzung für 'CE conformity mark' von Englisch nach Deutsch

CE conformity mark

CE-Konformitätszeichen {n}econ.EUtech.

• For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union.
• By including this statement the oxygen concentrator manufacturer is complying with the harmonised EN ISO type standard for oxygen concentrators EN ISO 8359:2009+A1:2012, which provides the manufacturer with an immediate presumption of conformity to the Essential Requirements of the Medical Devices Directive and allows them to properly apply the CE mark.
• Following completion of a successful conformity assessment procedure, Strata Skin Sciences has also been granted CE Mark approval for sale of MelaFind® in the European Union.
• On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards.
• Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive.

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• In addition, manufacturers are now obliged to provide conformity risk assessments and test reports – or explain why they are lacking.