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0537

Eurofins Electric & Electronics Finland Oy

🇫🇮 Finland · Espoo. Active

www.eurofins.fi/expertservices

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex IX(I), Annex XI(A)
Designated since2024-01-22
MDA 0201Active non-implantable imaging devices utilising ionizing radiation MDA 0202Active non-implantable imaging devices utilising non-ionizing radiation MDA 0203Active non-implantable devices for monitoring of vital physiological parameters MDA 0204Other active non-implantable devices for monitoring and / or diagnosis MDA 0302Active non-implantable devices utilising non-ionizing radiation MDA 0303Active non-implantable devices utilising hyperthermia / hypothermia MDA 0305Active non-implantable devices for stimulation or inhibition 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 0317Active non-implantable devices for cleaning, disinfection and sterilisation MDA 0318Other active non-implantable devices MDN 1102Non-active osteo- and orthopaedic implants 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 1204Non-active non-implantable devices for wound and skin care MDN 1206Non-active non-implantable ophthalmologic devices MDN 1207Non-active non-implantable diagnostic 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 1213Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route 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 IX(I), Annex XI(A)
Procedures
  • Conformity assessment based on product quality assurance, Conformity assessment based on a quality management system
Products
  • MDN 1102 Non-active osteo- and orthopaedic implants
  • MDN 1208 Non-active non-implantable instruments
  • MDN 1204 Non-active non-implantable devices for wound and skin care
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
  • MDA 0318 Other active non-implantable devices
  • MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
  • MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
  • MDA 0308 Active non-implantable devices for wound and skin care
  • 3. Active non-implantable therapeutic devices and general active non-implantable devices
  • A. Active devices
  • MDA 0310 Active non-implantable devices for ear, nose and throat
  • MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
  • MDN 1206 Non-active non-implantable ophthalmologic devices
  • 2. Non-active non-implantable devices
  • MDA 0312 Other active non-implantable surgical devices
  • MDA 0305 Active non-implantable devices for stimulation or inhibition
  • MDA 0311 Active non-implantable dental devices
  • MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
  • MDN 1207 Non-active non-implantable diagnostic devices
  • I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
  • 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • 1. Non-active implants and long term surgically invasive devices
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
  • MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
  • MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
  • MDN 1209 Non-active non-implantable dental materials
  • MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
  • MDA 0315 Software
  • MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  • B. Non-active 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=0537

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.