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3121

NOTICE, storitve ugotavljanja skladnosti, d.o.o.

🇸🇮 Slovenia · Ljubljana Active

www.notice.si

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex IX(I), Annex IX(II), Annex XI(A)
Designated since2025-10-07
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 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 0312Other active non-implantable surgical devices MDA 0315Software MDA 0318Other active non-implantable devices MDN 1101Non-active cardiovascular, vascular and neurovascular implants MDN 1102Non-active osteo- and orthopaedic implants MDN 1103Non-active dental implants and dental materials MDN 1104Non-active soft tissue and other 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 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 1206Non-active non-implantable ophthalmologic 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 IX(II), Annex XI(A)
Procedures
  • Conformity assessment based on a quality management system, Conformity assessment based on product quality assurance, Conformity assessment based on assessment of technical documentation
Products
  • MDA 0318 Other active non-implantable devices
  • MDN 1104 Non-active soft tissue and other implants
  • MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • MDN 1102 Non-active osteo- and orthopaedic implants
  • MDN 1204 Non-active non-implantable devices for wound and skin care
  • MDN 1103 Non-active dental implants and dental materials
  • 1. Non-active implants and long term surgically invasive devices
  • 2. Non-active non-implantable devices
  • MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
  • 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
  • I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
  • 3. Active non-implantable therapeutic devices and general active non-implantable devices
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
  • MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
  • MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • B. Non-active devices
  • A. Active devices
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
  • MDA 0308 Active non-implantable devices for wound and skin care
  • MDA 0315 Software
  • MDN 1206 Non-active non-implantable ophthalmologic devices
  • MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
  • 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
  • MDA 0312 Other active non-implantable surgical devices
  • MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
  • MDN 1208 Non-active non-implantable instruments
  • MDA 0307 Active non-implantable respiratory devices
  • MDN 1209 Non-active non-implantable dental materials
MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex IX(I), Annex IX(II), Annex XI(A)
Designated since2025-10-07
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 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 0312Other active non-implantable surgical devices MDA 0315Software MDA 0318Other active non-implantable devices MDN 1101Non-active cardiovascular, vascular and neurovascular implants MDN 1102Non-active osteo- and orthopaedic implants MDN 1103Non-active dental implants and dental materials MDN 1104Non-active soft tissue and other 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 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 1206Non-active non-implantable ophthalmologic 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 IX(II), Annex XI(A)
Procedures
  • Conformity assessment based on a quality management system, Conformity assessment based on product quality assurance, Conformity assessment based on assessment of technical documentation
Products
  • MDA 0318 Other active non-implantable devices
  • MDN 1104 Non-active soft tissue and other implants
  • MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • MDN 1102 Non-active osteo- and orthopaedic implants
  • MDN 1204 Non-active non-implantable devices for wound and skin care
  • MDN 1103 Non-active dental implants and dental materials
  • 1. Non-active implants and long term surgically invasive devices
  • 2. Non-active non-implantable devices
  • MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
  • 2. Active non-implantable devices for imaging, monitoring and/or diagnosis
  • I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
  • 3. Active non-implantable therapeutic devices and general active non-implantable devices
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices
  • MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
  • MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • B. Non-active devices
  • A. Active devices
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
  • MDA 0308 Active non-implantable devices for wound and skin care
  • MDA 0315 Software
  • MDN 1206 Non-active non-implantable ophthalmologic devices
  • MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
  • 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
  • MDA 0312 Other active non-implantable surgical devices
  • MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
  • MDN 1208 Non-active non-implantable instruments
  • MDA 0307 Active non-implantable respiratory devices
  • MDN 1209 Non-active non-implantable dental materials
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=3121

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.