MDR: 43rd Notified Body on NANDO!

The NANDO database has a new Notified Body under the MDR!

The extract from the Notification:

• MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
  • Except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices
• MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
  • Except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices
• MDA 0315 Software
  • Except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices
• MDN 1102 Non-active osteo- and orthopaedic implants
  • Except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices
• MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
  • Except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices
• MDA 0316 Medical gas supply systems and parts thereof
  • Except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices
• MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
  • Except IIIrd class devices, annex XI (A) only Is, Im, Ir, IIa class devices
• MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)
• MDS 1005 Devices in sterile condition
  • Assesptic processing, ethylene oxid gas sterilisantion (EOG), moist heat sterilisation, radiation sterilisation (only gamma), thermic sterilisation with dry heat
• MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
  • Including only for products with high intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment

The full designation scope is available here.

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