CE mark

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CE mark

logo awarded by the Medical Devices Agency (MDA) denoting that the device manufacturer has been appropriately registered under EEC Directive 93/42 (Box 1)
Box 1: Registration with the Medical Devices Agency (MDA)
References in periodicals archive ?
Two years on from raising concerns that some safety footwear with EC type approval and CE marking is not fit for purpose ARCO, a leading UK safety company, reports it has found further evidence of CE marked PPE products failing to meet required standards.
CE marking is a mandatory quality and safety conformity mark for products placed on the market in the European Economic Area, consisting of the 27 member states of the EU and European Free Trade Association countries Iceland, Liechtenstein and Norway.
CE marking rights have been secured by Ruukki for welded steel structures in building construction projects.
This article of the MDD allows an entity--an assembler--that "puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers" and satisfies a few other requirements to market the products without bearing an additional CE marking.
CorMedix") (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced today that it submitted its design dossier to a prominent European notified body as part of the CE Marking approval process for Neutrolin in the prevention of Catheter Related Bloodstream Infections ("CRBI") and maintenance of catheter patency in hemodialysis catheters.
Ruukki has obtained CE marking rights for welded steel structures in building construction projects.
CE Marking Opens Door to Wider Sales and Marketing of IMX Products
has received the European Union CE marking for its unique hemorrhage control ChitoFlex bandage.
The INTERCEPT Blood System for both platelets and plasma has received approval for CE marking in Europe, and a Phase I trial of the INTERCEPT Blood System for red cells is in progress in the United States.
CE marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European safety legislation.
Dune also announced that the company has received the European Union CE Marking (Communaute Europeenne) designation for its disposable BP probe and console system.
In addition to the CE marking, HemCon has also earned ISO 13485:2003 certification, the international quality management standard for designers and manufacturers of medical devices.