Dear Sir or Madam,
We are very pleased to inform you that we have received the IVDR certificate for our class C products with identifier HX 1098896-1 and effective date 2024-05-16. It is certified that requirements according to REGULATION (EU) 2017/746 on In Vitro Diagnostic Medical Devices Annex IX Chapter I, Section 2 and 3 and Chapter III are fulfilled for the covered products of class C. The certificate is shared on our homepage here: Quality and Certificates
As a next step, we will finalize and release all related documents. New productions of class C products will refer to the issued IVDR certificate.
If you have any further questions or comments, don't hesitate to contact us.
With best regards,
Institut Virion\Serion GmbH
Phone: +49 931 / 30 45 0
Mail: regulatory@virion-serion.de