MDR: 21 Notified Bodies on NANDO!

The NANDO database newly lists 21 Notified Bodies under the MDR!

KIWA CERMET ITALIA S.P.A. has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

KIWA CERMET ITALIA S.P.A.

Via Cadriano, 23
40057 – Cadriano di Granarolo (BO)
Country : Italy

Phone : +39 051 4593111
Fax : +39 051 763382

Email : infobologna@kiwacermet.it
Website : www.kiwacermet.it

Notified Body number : 0476

You can find the full scope of its notification on the following link. Below, an extract from NANDO, where conditions are listed :

• 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
  MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
  • Excluded magnetic resonance
•  3. Active non-implantable therapeutic devices and general active non-implantable devices
   MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
• 3. Active non-implantable therapeutic devices and general active non-implantable devices
  MDA 0307 Active non-implantable respiratory devices
  • Excluding hyperbaric chamber for oxygen therapy
• 3. Active non-implantable therapeutic devices and general active non-implantable devices
  MDA 0310 Active non-implantable devices for ear, nose and throat
  • Limited to ear equipment
• 3. Active non-implantable therapeutic devices and general active non-implantable devices
  MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)
  • Excluded in vitro fertilisation (IVF) and assisted reproductive technologies (ART) 
• 2. Non-active non-implantable devices
  MDN 1212 Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
  • Excluded in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
• MDS 1001 Devices incorporating medicinal substances
  • Excluding plasma and blood derivatives
• MDS 1005 Devices in sterile condition
  
  • The following processes are covered: aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, dry heat sterilization, radiation sterilisation (gamma-ray, x-ray, electron beam)
• MDS 1013 Class III custom-made implantable devices
  • Limited to devices within the scope of designation related to MDN codes
• MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
  • Limited to processing of materials of animal and microbial origin
• MDT 2012 Devices which require installation, refurbishment
  • Limited to devices which require installation
• MDT 2013 Devices which have undergone reprocessing
  • Limited to reusable devices which have to undergone reprocessing
• …

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