Ad
related to: ce mark device search
Search results
Results from the WOW.Com Content Network
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.
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.
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.
Receipt of the CE Mark followed by a limited launch of the WATCHMAN FLX device in Europe is likely to drive top-line contributions from Boston Scientific's (BSX) IC suite.
The device provides information on a lesion's level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. [1] MelaFind received CE Mark approval in November 2011 and is approved for use in the European Union.
PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYS: STJ) , a global medical device company, today announced European CE Mark approval of its ViewFlex ™ Xtra Intracardiac Echocardiography ...
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 ...
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
Ad
related to: ce mark device search