Our dispensing units are certified under the MDR
We are delighted to announce another important milestone: our dispensing units have been successfully certified under the Medical Device Regulation (EU) 2017/745 (MDR) as Class I medical devices with a measuring function. EU Quality Assurance Certificate No. 2026-MDR/QA-037/A was issued by the notified body 3EC International (NB 2265) and is valid from 17 July 2026.
We have been working towards this certification continuously since 2016, and we are very pleased to have brought this long journey to a successful end. We would like to thank our whole team for their perseverance and the work they put into it.
The certified units are: Automatic Dispensing Unit PT317R7, Automatic Dispensing Unit Twin Tracer PT459R5 and Manual Dispensing Unit PT468R4.
At the same time, our quality management system was certified to EN ISO 13485:2016.
You can download the certificate in English (PDF) or Czech (PDF). You can also verify it in the European database on medical devices, EUDAMED.
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Lynax certified to ISO 13485
We are delighted to announce that, since 17 July 2026, our quality management system for medical devices has been certified to EN ISO 13485:2016. The certificate was issued by the certification body 3EC International.
