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0425

ICIM S.P.A.

🇮🇹 Italy · - Sesto San Giovanni (MI) Active

www.icim.it

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex II, Annex V, Annex III, Annex IV, Annex VI
Designated since2006-04-09
Full scope text from the register
Annexes
  • Annex II, Annex V, Annex III, Annex IV, Annex VI
Procedures
  • EC verification, EC type-examination, Production quality assurance, Product quality assurance, Full quality assurance system
Products
  • Products and accessories for surgical use, such as suture needles, syringes, surgical gloves
  • Medical gas pipeline systems
  • capnometers
  • Pulse oxymeters
  • Devices, materials and apparatus for dental treatment
  • fever thermometers (active)
  • dental equipment (units, treatment chairs, etc.)
  • Dressings
  • contact lenses
  • Blood pressure measurement devices
  • Catheters and accessories
  • Devices for anaesthesia and ventilation
  • Operating theatre equipment
  • Non-active class I devices with a measuring function
  • Non active devices specifically intended for recording of X-ray diagnostic images. (Annex IX, 4.4. Rule 16)
  • disinfection and sterilization equipment
  • Single Usage Device (?)
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=0425

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.