Hemcheck’s hemolysis detection test for vacuum tubes, the most common type of blood sample collector in healthcare, has obtained a CE-mark. The CE-mark is a certification of compliance to health and safety standards that must be obtained before the product can be sold to hospitals, GPs and other health facilities in Sweden and Europe.
The CE-mark is the end result of a long chain of processes involving user demands, documentation, technical and regulatory requirements, safety requirements, user tests, and validation of the production process, which are examined as a whole, and when successful culminate in a CE-mark.
– I’m proud and happy that, just as planned, we have CE marked both our systems, that is for blood samples with vacuum tubes and our test for blood gas syringes before the end of 2018. We have now started to process the market and, as we have been able to tell earlier, during the autumn we have strengthened our organization in several areas ahead of the coming launch. SHL Group and Scanfil, our partners in production, are already working on their preparations to start producing larger series on our behalf, ”says Hemcheck’s CEO Annelie Brolinson.
For further information, please contact Annelie Brolinson, CEO, firstname.lastname@example.org, +46 70 2880826