MDR: 18th Notified Body on NANDO!

The NANDO database newly lists 18 Notified Bodies under the MDR!

UDEM Adriatic is the 18th Notified Body (17th within the Union) notified under the Regulation (EU) 2017/745 on medical devices – MDR.

UDEM Adriatic d.o.o.
Radnička cesta 54/R3
Zagreb
Country : Croatia

Phone : +38514819601
Fax : +38514819434

Email : info@udemadriatic.com
Website : www. udemadriatic.com

Notified Body number : 2696

You can find the full scope of its designation on the following link.

Here below, an extract of the exclusion from the notification:

• Active non-implantable devices for imaging, monitoring and/or diagnosis
  MDA 0201 Active non-implantable imaging devices utilising ionizing radiation excluding gamma ray devices
• Non-active implants and long term surgically invasive devices
  MDN 1101 Non-active cardiovascular, vascular and neurovascular implants excluding heart valves
• Non-active implants and long term surgically invasive devices
  MDN 1104 Non-active soft tissue and other implants excluding breast implants
• MDS 1001 Devices incorporating medicinal substances excluding human blood derivatives
• MDT 2012 Devices which require installation, refurbishment excluding refurbishment

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