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  2. CE marking - Wikipedia

    en.wikipedia.org/wiki/CE_marking

    CE marking example on a mobile phone charger. The presence of the logo (from French, "conformité européenne" meaning "European conformity") [2] on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.

  3. Type approval - Wikipedia

    en.wikipedia.org/wiki/Type_approval

    The CE mark found on the back of many electronic devices does not mean that the product has obtained type approval in the European Union. The CE mark is the manufacturer's declaration that the system/assembly meets the minimum safety requirements of all the directives (laws) applicable to it, and of itself, does not signify any third party ...

  4. Notified body - Wikipedia

    en.wikipedia.org/wiki/Notified_Body

    CE Mark. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.

  5. St. Jude Medical Announces CE Mark Approval of Next ... - AOL

    www.aol.com/news/2013-05-08-st-jude-medical...

    St. Jude Medical Announces CE Mark Approval of Next-Generation Ellipse and SJM Assura High Voltage Devices Next-generation implantable defibrillators feature additional safety features to elevate ...

  6. European Authorized Representative - Wikipedia

    en.wikipedia.org/wiki/European_Authorized...

    As clarified in the Medical Devices Directive — Directive 93/42/EEC [4] — it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities.

  7. St. Jude Medical Receives CE Mark of Next-Generation ... - AOL

    www.aol.com/news/2013-01-18-st-jude-medical...

    St. Jude Medical Receives CE Mark of Next-Generation Cardiac Device for Stroke Prevention AMPLATZER Amulet unveiled at 18th annual Boston AF Symposium ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude ...

  8. St. Jude Medical Receives European CE Mark Approval of ... - AOL

    www.aol.com/2012/09/20/st-jude-medical-receives...

    St. Jude Medical Receives European CE Mark Approval of Eon Mini Neurostimulator, the World's Smallest Rechargeable Device to Treat Chronic Migraine Additional approvals received for Eon and EonC ...

  9. Product certification - Wikipedia

    en.wikipedia.org/wiki/Product_certification

    product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).

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