Lumito has CE-marked its first product, SCIZYS. This is an important milestone for Lumito and means that sales for the histopathological research market can begin. SCIZYS S1 now fulfils all the relevant provisions of the EC Machinery Directive 2006/42/EC.
The internal work required to be able to CE mark the product after receiving the final report from the independent testing institute Nemko was completed on Thursday, and a "Declaration of Conformity" has now been signed. This declares that SCIZYS S1 now conforms with the following EU Directives: the Low Voltage Directive (2014/35/EU), the EMC Directive (2014/30/EU), and the RoHS Directive (2011/65/EU + 2015/863).
"It is with incredible pride and great joy that we have now, after a long period of hard work with the compliance testing, been confirmed that we meet all the requirements set to be able to CE mark a product aimed at the research market. This, together with the technical documentation, means that we finally were able to sign a Declaration of Conformity and thus CE mark Lumito's first product, SCIZYS. We are now ready to offer customers our solution and the company is fully entering a commercial phase", comments Lumito's CEO Mattias Lundin.
A CE mark for a product aimed at research is a self-declared CE mark and means that Lumito themselves signed a declaration of agreement, a so-called Declaration of Conformity.
