Oficiul Tehnic de Dispozitive Medicale Certificare-OTDM CERTIFICARE

🇷🇴 Romania · Bucuresti Withdrawn

www.otdm-certificare.ro

Designations

MDR Medical devices · Regulation (EU) 2017/745 Withdrawn

Conformity assessment annexesAnnex V, Annex II

Designated since2015-08-19

Full scope text from the register

Annexes

Annex V, Annex II

Procedures

EC declaration of conformity (full quality assurance system), EC declaration of conformity (production quality assurance)

Products

*MD 1100 - General active medical devices
*MD 0201 - Non-active cardiovascular implants
*MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
*MD 0400 - Non-active dental devices and accessories
*MD 1106 - Active dental devices
*MD 1109 - Active devices for patient positioning and transport
*MD 0105 - Non-active ophthalmologic devices
*MD 1105 - Active ophthalmologic devices
*MD 0204 - Non-active soft tissue implants
*MD 1302 - Monitoring devices of vital physiological parameters
*MD 1200 - Devices for imaging
*MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
*MD 1403 - Devices for hyperthermia / hypothermia
*MD 1400 - Devices for radiation therapy and thermo therapy
*MD 0107 - Contraceptive medical devices
*MD 0100 - General non-active, non-implantable medical devices
*MD 0403 - Dental implants
*MD 1402 - Devices utilising non-ionizing radiation
*MD 1301 - Monitoring devices of non-vital physiological parameters
*MD 1103 - Devices for stimulation or inhibition
*MD 1401 - Devices utilising ionizing radiation
*MD 0203 - Non-active functional implants
*MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
*MD 0401 - Non-active dental equipment and instruments
*MD 0200 - Non-active implants
*MD 0300 - Devices for wound care
*MD 1108 - Active rehabilitation devices and active prostheses
*MD 0103 - Non-active orthopaedic and rehabilitation devices
*MD 0104 - Non-active medical devices with measuring function
*MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
*MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
*MD 1107 - Active devices for disinfection and sterilisation
*MD 1111 - Software
*MD 1202 - Imaging devices utilising non-ionizing radiation
*MD 0202 - Non-active orthopaedic implants
*MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
*MD 0301 - Bandages and wound dressings
*MD 0302 - Suture material and clamps
*MD 0106 - Non-active instruments
*MD 0303 - Other medical devices for wound care
*MD 0402 - Dental materials
*MD 1104 - Active surgical devices
*MD 1300 - Monitoring devices
*MD 1201 - Imaging devices utilising ionizing radiation

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=1868

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.