ISO 9001:2015 Quality Management System

UDEM Adriatic d.o.o. is accredited certification company related to ISO 9001:2015 and you can find our certification scope on this link

ISO 13485:2016 Medical Devices Quality Management System

UDEM Adriatic d.o.o. is accredited certification company related to ISO 13485:2016 and you can find our certification scope on this link

2017/745/EU Medical Devices Regulation

UDEM Adriatic d.o.o. is a Notified Body related 2017/745/EU Medical Devices Regulations at Annex IX(I), Annex IX(II) and Annex XI(A). We are designated at NANDO - Number 2696. 

UDEM Adriatic MDR Scope

2006/42/EC Machinery Directive

UDEM Adriatic d.o.o. is an Accredited Notified Body related 2006/42/EC Machinery Directive at Annex IV from Croatian Accreditation Agency according to ISO/IEC 17065. We are designated at NANDO - Number 2696. 

UDEM Adriatic Certification Scope at Annex IV