The National Institute of Pharmacy and Nutrition hereby certifies, that on the basis of information provided, the medical device(s) names below and detailed in the attachment (if applicable), which is/are manufactured by the above economic operator, has/have been affixed with the CE mark under the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices and/or the Council Directive 93/42/EEC concerning medical devices (as amended) which was transposed into Hungarian national law (decree No. 8/2003. (III. 13) of the Ministry of Health, Social and Family Affairs on in vitro diagnostic medical devices and/or decree No. 4/2009 (III. 17) of the Ministry of Health on medical devices, as amended, may be freely sold in all member states of the European Economic Area (EEA) including Hungary.