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The CE marking as it has been legally called since 1993, formerly EC mark is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives. However, "CE" originally stood for ("Communauté Européenne", "Comunidad Europea", "Comunidade Europeia" and "Comunità Europea") "European Community". Legally, the CE marking is not a quality mark. But, depending on the applicable directive, the CE marking can actually be considered to be a quality mark. Deviating from sectoral directives regulating other industrial goods, medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC. According to this, medical devices must not only be safe but also function in a medical-technical way as described in the manufacturer's "intended purpose". Compliance with these requirements is proved within a certified quality management system according to EN ISO 13485.



UL is an independent product safety certification organization. UL develops standards and test procedures for products, materials, components, assemblies, tools and equipment, chiefly dealing with product safety. UL also evaluates and certifies the efficiency of a company's business processes through its management system registration programs. UL is one of several companies approved for such testing by the U.S. federal agency Occupational Safety and Health Administration (OSHA). OSHA maintains a list of approved testing laboratories, known as Nationally Recognized Testing Laboratories.



The TUV Rheinland GS S1certificate is a certificate presented to manufacturers as the de facto certificate for acceptance into Europe. The certificate can be considered the de facto certificate because it not only demonstrates full compliance with the GPSG (German equipment safety law) for Germany, but it also demonstrates compliance to the LVD (minimum EU requirement). S1 Certificates include a statement that Annex I of the LVD (2006/95/EC) is complied with. The certificate can be used in connection with the manufacturers EC-declaration of conformity according to Annex III.



The Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment 2002/95/EC; commonly referred to as the Restriction of Hazardous Substances Directive or RoHS was adopted in February 2003 by the European Union. The RoHS directive took effect on 1 July 2006, and is required to be enforced and become law in each member state. This directive restricts the use of six hazardous materials in the manufacture of various types of electronic and electrical equipment. It is closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC which sets collection, recycling and recovery targets for electrical goods and is part of a legislative initiative to solve the problem of huge amounts of toxic e-waste.




Koledo is headquartered at Esp 214 in Eindhoven, The Netherlands with primary operations based in i.a. Asia, United States and across all major countries in Europe.