MDR: 44th Notified Body on NANDO!

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

The extract from the Notification:

• • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
    • Class III excluded, EEG excluded
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
    • Class III excluded
  • MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
    • Class III excluded, Short wave diathermy excluded
  • MDA 0305 Active non-implantable devices for stimulation or inhibition
    • Class III excluded
  • MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
    • Class III excluded, Heart-lung-bypass pump/Extracorporeal Membrane Oxygenation (ECMO) excluded, Intra-aorthic Balloon Pump excluded
  • MDA 0307 Active non-implantable respiratory devices
    • Class III excluded
  • MDA 0308 Active non-implantable devices for wound and skin care
    • Class III excluded
  • MDA 0310 Active non-implantable devices for ear, nose and throat
    • Class III excluded
  • MDA 0311 Active non-implantable dental devices
    • Class III excluded
    • Restricted to: Powered dental surgical unit and hand pieces, Surgical suction device for dental use
  • MDA 0312 Other active non-implantable surgical devices
    • Class III excluded
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
    • Class III excluded
  • MDA 0315 Software
    • Class III excluded
  • MDA 0316 Medical gas supply systems and parts thereof
    • Class III excluded, Medical gas pipeline system excluded
  • MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
    • Class III excluded, Sterilization devices excluded
  • MDA 0318 Other active non-implantable devices
    • Class III excluded
  • MDN 1102 Non-active osteo- and orthopaedic implants
    • Class III excluded
    • Restricted to: Orthopaedic nails, screws, plates, and Sutures, suture anchors, staples for orthopedic surgery
  • MDN 1103 Non-active dental implants and dental materials
    • Class III excluded
  • MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
    • Class III excluded
  • MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
    • Class III excluded
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
    • Class III excluded
    • Restricted to: Periferal vascular catheters and related tools
  • MDN 1204 Non-active non-implantable devices for wound and skin care
    • Class III excluded
  • MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
    • Class III excluded
  • MDN 1208 Non-active non-implantable instruments
    • Class III excluded
  • MDN 1209 Non-active non-implantable dental materials
    • Class III excluded
  • MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
    • Class III excluded, Catheter lock solutions excluded, and Solutions for disinfecting contact lenses excluded
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
    • Class III excluded

The full designation scope is available here.

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