EXBIO IVD Medical Devices are in compliance with the IVDR!

We are thrilled to announce that our IVD medical devices, intended for flow cytometry application meet the requirements on quality management system according to the Regulation (EU) 2017/746 of the European Parliament and of the Council as ammended (IVDR).

Based on sucessfull initial assessment of the quality management system of abovementioned IVD medical devices by Notified Body (concluded by issued EU Quality Management System Certificate No. 2024-IVDR/QS-004), we have drawn up and signed EU Declaration of Conformity (DoC) on 01.07.2024 and 09.12.2024.

It is available upon request, please do not hesitate to contact us at info@exbio.cz.

The new IVDR compliant batches of the products will be placed on the market during the Q4/2024 and Q1/2025, and at the same moment the product pages on our website will also be updated (specifically new version of IFU).