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 above mentioned 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).
ED7733 KOMBITEST TBNK 6-color
ED7734 KOMBITEST T Cell 4-color
ED7735 KOMBITEST B/NK Cell 4-color
ED7736 DryFlowEx TBNK 6-color
ED7750 DryFlowEx PNH High-Sensitivity Assay Kit
ED7080 CD34 QuantiFlowEx Kit
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 in 2025:
ED7043 BasoFlowEx Kit
ED7042 FagoFlowEx kit
ED7040 IngoFlowex kit (currently RUO product)
The last round of the IVDR conformity assessment for the remaining products is planned to 2025 / 2026:
ED7642 T-cell BlastoFlowEx (currently RUO product)
ED7078 NKFlowEx kit (currently RUO product)
We will be keeping you updated. Thank you very much for your continuous support!
Jolana Vosahlova and Sales Team
info@exbio.cz