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Last updated on April 23, 2014 at 12:06 EDT

Latest CE mark Stories

2013-02-27 08:23:54

REUTLINGEN, Germany, February 27, 2013 /PRNewswire/ -- - CE documentation and several years of document archiving will become obligatory In addition to the Chemicals Regulation REACH (Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals), medical devices will have to comply with the European RoHS Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment in the future: As of July...

2013-01-07 16:25:48

CASTLE ROCK, Colo., Jan. 7, 2013 /PRNewswire/ -- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today announced it has fulfilled the requirements for CE Marking in Europe for APPY1, the Company's blood-based appendicitis test. Initial commercialization in Europe is planned to commence in the first quarter 2013 in key territories, including the UK, Italy, France, Germany and Benelux countries. The Company expects to announce agreements with top EU distributors beginning in the...

2012-11-30 08:24:44

SACRAMENTO, Calif., Nov. 30, 2012 /PRNewswire/ -- SynGen Inc., a company focused on the development and commercialization of medical systems that harvest stem and progenitor cells, from cord blood, bone marrow, peripheral blood, and other tissues, announced today that it has achieved two key regulatory milestones. The Company was awarded an ISO 13485:2003 Certificate of Registration and a Full Quality Assurance certificate by the British Standards Institution (BSI), which allows it to CE...

2012-09-05 23:00:13

Konan Medical USA's new RAPDx high definition pupillograph has received Europe's CE Mark and sales will begin in Europe and other countries recognizing the CE Mark beginning at the largest European Ophthalmic congress, the ESCRS, in Milan, Italy. Irvine, CA (PRWEB) September 04, 2012 Konan Medical USA, Inc. has announced that its RAPDx® pupillograph for screening of defects in pupil function has received the European CE Mark. The CE Mark identifies that the RAPDx device has met the...

2012-08-17 06:22:11

CHICAGO, Aug. 17, 2012 /PRNewswire/ -- Positron Corporation (OTCBB:POSC), a leading molecular imaging healthcare company, is pleased to announce that Neusoft Positron Medical Systems Co., Ltd., has received ISO certification (9001:2008 & 13485:2003) and CE Mark approval for their Attrius® PET Systems. Neusoft Positron Medical Systems is a joint venture between Neusoft Medical Systems Co., Ltd., and Positron Corporation for the development and manufacturing of PET systems and is based...

2012-07-12 14:23:45

TAMPA, Fla., July 12, 2012 /PRNewswire-iReach/ -- Integrity Life Sciences announced today that on March 30th, 2012 TÃœV SÃœD Product Service GmbH of Munich, Germany issued to Integrity the CE Marking (Certificate of European Conformity) and compliance with these requirements is proved within a certified quality management system according to EN ISO 13485 (International Standards Organization). Integrity Life Sciences was granted by TUV SUD the CE Mark together with an...

2012-06-28 06:29:23

RESTON, Va., June 28, 2012 /PRNewswire/ -- For U.S.-based medical device start-ups, speed to global markets is often the most pressing concern, but trying to move too fast often leads to preventable mistakes that could take the CE Marking process back to the drawing board, according to healthcare experts at BSI Group America, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union. (Logo:...

2012-06-20 18:22:42

SOMERSET, N.J., June 21, 2012 /PRNewswire-iReach/ -- Vyzin, Inc. announced today it has passed all the necessary tests and has been awarded CE, ROHS and SAR certifications for its mobile health (mHealth) solution VESAG. (Photo: http://photos.prnewswire.com/prnh/20120620/CG28390) VESAG mobile-based personal emergency response system (MPERS) is a watch providing proactive remote health monitoring and recording of patient vitals without the need to see a healthcare provider. VESAG helps those...

2012-03-28 02:25:24

SCHWABMUNCHEN, Germany, March 28, 2012 /PRNewswire/ -- Elekta's Connexion(TM) modular couchtop is CE marked and successfully released for sale in the European Union. Connexion meets the clinic's need to tailor patient set-up to accommodate the unique therapy requirements of the individual patient. With a growing range of imaging and treatment techniques available, couchtops need to be able to support different approaches without compromising patient set-up. With its distinctive...

2011-12-30 08:00:00

Shindo Industry (represented by CEO Yong-Soon) stands as Asia´s first company to obtain CE Mark (EC Certificate of Conformity) approval for its state of the art series of independently developed Cushion Tank Systems: EU-CCS110, EU-CCS100, EU-CCS80 and EU-CCS50. (PRWEB) December 30, 2011 Shindo Industry (represented by CEO Yong-Soon) stands as Asia´s first company to obtain CE Mark (EC Certificate of Conformity) approval for its state of the art series of independently developed...