Hemcheck has today finalised all documentation and sent the required documents to the Medical Products Agency in Sweden to comply with the new IVDR regulations. The work has been ongoing for a long time at Hemcheck, and compliance to the IVDR regulations is a requirement to maintain the CE marking from May 26, 2022 onwards.
– It has been a lot of work to adapt our company and our documentation to comply with the new regulations in all relevant parts, which are very comprehensive. It is of course satisfying that we have reached this milestone and I would like to thank the team at Hemcheck who all contributed to the work, says Joen Averstad, CEO of Hemcheck.
For further information contact:
Hemcheck Sweden AB (publ)
Joen Averstad, CEO
Tel: +46 76 108 8191
Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection. The concept consists of disposable tests as well as readers that can very quickly, directly upon sampling, identify hemolysed blood samples in vacuum tubes and blood gas syringes. Hemolysis, ruptured red blood cells, is the most common reason globally why blood samples cannot be analyzed accurately. Hemcheck’s goal is to contribute to improved healthcare by offering user-friendly services for the detection of hemolysed blood samples in direct connection with blood sampling. By doing so, Hemcheck can contribute to increased patient safety, more efficient processes and lower costs. The company is listed on the Nasdaq First North Growth Market.
FNCA Sweden AB, 08-528 00 399, info@fnca, is the Certified Adviser to the company.