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0481

ecm-Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH

🇩🇪 Germany · Aachen Active

www.medi-online.com

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex VI, Annex II, Annex V
Designated since2019-09-06
Full scope text from the register
Annexes
  • Annex VI, Annex II, Annex V
Procedures
  • EC declaration of conformity (production quality assurance), Product quality assurance, EC declaration of conformity (full quality assurance system), EC declaration of conformity (product quality assurance), Production quality assurance, Full quality assurance system
Products
  • *MD 0303 - Other medical devices for wound care
  • *MD 1104 - Active surgical devices
  • *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
  • *MD 1100 - General active medical devices
  • *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
  • *MD 0106 - Non-active instruments
  • *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
  • *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
  • *MD 0104 - Non-active medical devices with measuring function
  • *MD 0302 - Suture material and clamps
  • *MD 0401 - Non-active dental equipment and instruments
  • *MD 0202 - Non-active orthopaedic implants
  • *MD 0103 - Non-active orthopaedic and rehabilitation devices
  • *MD 0301 - Bandages and wound dressings
  • *MD 1400 - Devices for radiation therapy and thermo therapy
  • *MD 0402 - Dental materials
  • *MD 0200 - Non-active implants
  • *MD 0403 - Dental implants
  • *MD 0203 - Non-active functional implants
  • *MD 0201 - Non-active cardiovascular implants
  • *MD 0105 - Non-active ophthalmologic devices
  • *MD 0107 - Contraceptive medical devices
  • *MD 0110 - Non-active medical devices for ingestion
  • *MD 0300 - Devices for wound care
  • *MD 0100 - General non-active, non-implantable medical devices
  • *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
  • *MD 0400 - Non-active dental devices and accessories
  • *MD 1403 - Devices for hyperthermia / hypothermia
  • *MD 0204 - Non-active soft tissue implants
MDR Medical devices · Regulation (EU) 2017/745 Active
Conformity assessment annexesAnnex VI, Annex II, Annex V
Designated since2019-09-06
Full scope text from the register
Annexes
  • Annex VI, Annex II, Annex V
Procedures
  • EC declaration of conformity (production quality assurance), Product quality assurance, EC declaration of conformity (full quality assurance system), EC declaration of conformity (product quality assurance), Production quality assurance, Full quality assurance system
Products
  • *MD 0303 - Other medical devices for wound care
  • *MD 1104 - Active surgical devices
  • *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
  • *MD 1100 - General active medical devices
  • *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
  • *MD 0106 - Non-active instruments
  • *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
  • *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
  • *MD 0104 - Non-active medical devices with measuring function
  • *MD 0302 - Suture material and clamps
  • *MD 0401 - Non-active dental equipment and instruments
  • *MD 0202 - Non-active orthopaedic implants
  • *MD 0103 - Non-active orthopaedic and rehabilitation devices
  • *MD 0301 - Bandages and wound dressings
  • *MD 1400 - Devices for radiation therapy and thermo therapy
  • *MD 0402 - Dental materials
  • *MD 0200 - Non-active implants
  • *MD 0403 - Dental implants
  • *MD 0203 - Non-active functional implants
  • *MD 0201 - Non-active cardiovascular implants
  • *MD 0105 - Non-active ophthalmologic devices
  • *MD 0107 - Contraceptive medical devices
  • *MD 0110 - Non-active medical devices for ingestion
  • *MD 0300 - Devices for wound care
  • *MD 0100 - General non-active, non-implantable medical devices
  • *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
  • *MD 0400 - Non-active dental devices and accessories
  • *MD 1403 - Devices for hyperthermia / hypothermia
  • *MD 0204 - Non-active soft tissue implants
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=0481

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.