Certificate no. 104/MDR

On the basis of the assessment carried out according to the Annex IX chapters I and III of the Regulation (EU) 2017/745, IMQ S.p.A. as Notified Body certify that the full quality management system established, documented and implemented by EUROTEC MEDICAL SYSTEMS SRL
for the following devices:
Bone densitometer
complies and ensures the compliance of such devices with the applicable requirements of the aforementioned EU Regulation and it is subject to surveillance as required by the same Annex, section 3.

This EU Certificate is issued by IMQ S.p.A. as Notified Body no. 0051 for the Regulation (EU) 2017/745 related to medical devices.