Calmark CE marks product for assessing COVID-19 severity
Calmark Sweden AB (publ) announces today that the product Calmark COVID19-LDH has obtained its CE marking in accordance with the IVD directive. The product is now ready for sale and use in healthcare, including in the EU.The IVD directive encompasses requirements regarding safety, performance and function. The quality assurance of Calmark's product COVID19-LDH, for assessment of disease severity, is now successfully completed in all these regards.
In addition to giving Calmark authorization to sell the product within the EU, the CE Mark further opens up opportunities for accelerated