IVD Medical Devices KOMBITEST TBNK 6-color (Cat. No. ED7733) and DryFlowEx TBNK 6-color (Cat. No. ED7736) are in compliance with the IVDR!
We are thrilled to announce that our IVD medical devices, intended for detection and enumeration of lymphocyte population and subsets in human whole blood by flow cytometry, meets 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.
It is available upon request, please do not hesitate to contact us at info@exbio.cz.
The new IVDR compliant batches of the above mentioned products will be placed on the market during the fall of 2024, and at the same moment the product pages on our website will also be updated (specifically new version of IFU).
We are delighted with such a true milestone in our design and manufacture activities in IVD medical device industry. But we have not finished our path yet. Currently, we are heavily working on further IVD medical devices to be added to our EU Quality Management System Certificate in order to accomplish IVDR compliance till the end of 2024:
ED7750 DryFlowEx PNH High-Sensitivity Assay Kit
ED7734 KOMBITEST T Cell 4-color
ED7080 CD34 QuantiFlowEx Kit
ED7043 BasoFlowEx Kit
Dear Users, the third round of the IVDR conformity assessment for remaining products is planned to a summer 2025. We will be keeping you updated. Thank you very much for your continuous support.
Jolana Vosahlova and Sales Team
info@exbio.cz