What is the difference?
Answer:
*CryoLife, Inc. ("CryoLife" or the "Company") is the leader in the cryopreservation of viable human tissues for cardiovascular, vascular and orthopaedic transplant applications, and develops and commercializes additional
implantable products, including surgical bioadhesives. The Company estimates that it provided in excess of 70% of the cryopreserved human heart valve tissue implanted in the U.S. in 2000. The Company uses its expertise in biochemistry and cell biology, and its understanding of the needs of the cardiovascular, vascular and orthopaedic surgery medical specialties, to continue expansion of
its core cryopreservation business and to develop or acquire complementary implantable products and technologies for these fields. The Company develops and
markets proprietary implantable biomaterials, including BioGlue(R) surgical adhesive, which it began commercializing within the European Community ("EC") in
April 1998 and within the U.S. in December 1999. Additionally the Company develops bioprosthetic cardiovascular devices including two novel design
stentless porcine heart valves currently marketed in the EC. In November 2000 the Company received a Conformite Europeene ("CE") Mark (product certification) for commercial distribution of its SynerGraft(R) heart valve in the EC.
Domestically the Company began applying its proprietary SynerGraft technology in February 2000 to enhance the preservation of human heart valves.
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The CE mark (officially CE marking) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE mark" is still in use, but it is not the official term.
By affixing the CE marking, the manufacturer, its authorized representative, or person placing the product on the market or putting it into service asserts that the item meets all the essential requirements of all applicable EU directives and that the applicable conformity assessment procedures have been applied. Examples of European Directives requiring CE marking include toy safety, machinery, low-voltage equipment, R&TTE, and EM compatibility. There are about 25 Directives requiring CE marking. [1].
Officially, CE has no meaning as an abbreviation, but may have originally stood for Communauté Européenne or Conformité Européenne, French for European Conformity.
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