The CE mark is a mandatory European safety marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. To permit the use of a CE mark on a product, proof that the item meets the relevant requirements must be documented. Our products have passed a certification process and are in conformance with the In Vitro Diagnostics Medical Devices Directive 98/79/EC which are documented in our Declarations of Conformity and are signed by our European Representative.