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3033

TÜV NORD Scandinavia Medical Notified Body AB

🇸🇪 Sweden · 40 Kista Active

www.tuv-nord.com/scandinaviamnb

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex XI(A), Annex IX(II), Annex IX(I)
Designated since2024-03-07
MDA 0203Active non-implantable devices for monitoring of vital physiological parameters MDA 0204Other active non-implantable devices for monitoring and / or diagnosis MDA 0303Active non-implantable devices utilising hyperthermia / hypothermia MDA 0305Active non-implantable devices for stimulation or inhibition MDA 0306Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis MDA 0307Active non-implantable respiratory devices MDA 0308Active non-implantable devices for wound and skin care MDA 0310Active non-implantable devices for ear, nose and throat MDA 0311Active non-implantable dental devices MDA 0312Other active non-implantable surgical devices MDA 0313Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport MDA 0315Software MDA 0316Medical gas supply systems and parts thereof MDA 0317Active non-implantable devices for cleaning, disinfection and sterilisation MDA 0318Other active non-implantable devices MDN 1102Non-active osteo- and orthopaedic implants MDN 1103Non-active dental implants and dental materials MDN 1201Non-active non-implantable devices for anaesthesia, emergency and intensive care MDN 1202Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis MDN 1203Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools MDN 1204Non-active non-implantable devices for wound and skin care MDN 1205Non-active non-implantable orthopaedic and rehabilitation devices MDN 1208Non-active non-implantable instruments MDN 1209Non-active non-implantable dental materials MDN 1211Non-active non-implantable devices for disinfecting, cleaning and rinsing MDN 1214General non-active non-implantable devices used in health care and other non-active non-implantable devices
Full scope text from the register
Annexes
  • Annex XI(A), Annex IX(II), Annex IX(I)
Procedures
  • Conformity assessment based on a quality management system, Conformity assessment based on assessment of technical documentation, Conformity assessment based on product quality assurance
Products
  • B. Non-active devices
  • MDA 0310 Active non-implantable devices for ear, nose and throat
  • I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
  • A. Active devices
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • MDA 0318 Other active non-implantable devices
  • MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
  • MDA 0307 Active non-implantable respiratory devices
  • MDA 0311 Active non-implantable dental devices
  • MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
  • 2. Non-active non-implantable devices
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
  • MDN 1208 Non-active non-implantable instruments
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  • MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
  • MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
  • MDA 0316 Medical gas supply systems and parts thereof
  • MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
  • MDN 1209 Non-active non-implantable dental materials
  • 1. Non-active implants and long term surgically invasive devices
  • MDA 0305 Active non-implantable devices for stimulation or inhibition
  • MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
  • MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
  • 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
  • MDA 0312 Other active non-implantable surgical devices
  • MDN 1102 Non-active osteo- and orthopaedic implants
  • MDN 1204 Non-active non-implantable devices for wound and skin care
  • MDA 0308 Active non-implantable devices for wound and skin care
  • MDN 1103 Non-active dental implants and dental materials
  • MDA 0315 Software
  • 3. Active non-implantable therapeutic devices and general active non-implantable devices
Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=3033

This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.