Our products are 510k certified and comply with good manufacturing practice of the U.S. Food and Drug Administration. In order to sell our products to European countries, Dadsun has ISO-13485:2003,ISO-14971:2007, EN-980:2008,ISO-10993-1:2009,EN-1041:2008,ENISO-13544-1:2007,ENISO-13544-2:2002and 93/42/EEC(2007/47/EC) certification, to assure you that our products meet the world's highest standards for quality.