cemark.org
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As of 21 March 2010, a Single EEA European Authorised/Authorized Representative must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready?Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic MedicalDevices with MHRA & other EEA authorities by world-leading CE MarkingSpecialists based in London/UK. Click here to get FREE Guide Now!Do you export to Europe? Let Wellkang Group help you! Let a world leading consulting group be your professional & reliable European Authorised/Authorized Representative for CE marking (CE mark) of Medical Devices (MDD), Personal Protective Equipment (PPE), Low Voltage Electrical Equipment (LVD), Electromagnetic Compatibility (EMC), REACH Only Representative, WEEE and RoHS, Cosmetics, Toys, etc.Wellkang Group is a world leading consultancy group specialized in global regulatory affairs such as: European Union & EFTA product safety requirement- CE Marking; REACH; WEEE and RoHS compliance and solutions; European regulations on cosmetic products; US FDA compliance including Food registration, Medical device 510(k) PMN submission; UL mark; China Compulsory Certification- CCC Mark & China RoHS compliance and solutions, etc. Wellkang help worldwide exporters to gain global market access. Wellkang have offices in Asia, Europe and America. A world leading consultancy offers you excellent services at very competitive prices!How can Wellkang help you ?Wellkang's mission is to provide a comprehensive range of business services aimed at assuring the European product conformity. The in-depth expertise of our professionals and an extensive working experience in a wide industrial spectrum enable us to achieve this goal. Wellkang strives to establish a close, trusting relationship with our clients based on proven performance and total dedication to their products.EU Documentation and Standards Delivery Service.1.1 EU Product Directives1.2 European Standards1.3 Other EU Official DocumentsTechnical Consulting Service2.1 Technical Advice on Compliance Engineering2.2 Safety and Risk Assessments Compliance Testing Service3.1 Pre-compliance testing arrangement3.2 Full-compliance testing arrangementTechnical Documentation Service4.1 Technical Files (Technical Documentation):guiding you preparing this document.4.2 EC Declaration of Conformity:guiding you preparing this document, we have different models in several languages.Labeling and Document Translation (We can arrange the translation from English into the official language(s) of every EU member state)5.1 Users Manual and Installation Instructions5.2 Labeling Advice and TranslationEuropean (EEA/EU) Authorised/Authorized Representative Service6.1 Use of Wellkang's Name & Address:By appointing Wellkang as your European Authorised/Authorized Representative, you are allowed to print Wellkang's Name and Address on the packaging, labeling and sales literature of your CE-marked products in order to comply with the
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