NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

🇬🇷 Greece · 62 GLYFADA Active

www.ekapty.gr/

Designations

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

Conformity assessment annexesAnnex VI, Annex V, Annex II

Designated since2017-01-31

Full scope text from the register

Annexes

Annex VI, Annex V, Annex II

Procedures

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

Products

*MD 1200 - Devices for imaging
*MD 0303 - Other medical devices for wound care
*MD 0402 - Dental materials
*MD 1106 - Active dental devices
*MD 1302 - Monitoring devices of vital physiological parameters
*MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
*MD 0103 - Non-active orthopaedic and rehabilitation devices
*MD 0202 - Non-active orthopaedic implants
*MD 1100 - General active medical devices
*MD 0301 - Bandages and wound dressings
*MD 0107 - Contraceptive medical devices
*MD 0401 - Non-active dental equipment and instruments
*MD 0400 - Non-active dental devices and accessories
*MD 1103 - Devices for stimulation or inhibition
*MD 1400 - Devices for radiation therapy and thermo therapy
*MD 1300 - Monitoring devices
*MD 0105 - Non-active ophthalmologic devices
*MD 0300 - Devices for wound care
*MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
*MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
*MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
*MD 1402 - Devices utilising non-ionizing radiation
*MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
*MD 0104 - Non-active medical devices with measuring function
*MD 1201 - Imaging devices utilising ionizing radiation
*MD 0106 - Non-active instruments
*MD 1104 - Active surgical devices
*MD 1111 - Software
*MD 1108 - Active rehabilitation devices and active prostheses
*MD 1202 - Imaging devices utilising non-ionizing radiation
*MD 0200 - Non-active implants
*MD 1403 - Devices for hyperthermia / hypothermia
*MD 0204 - Non-active soft tissue implants
*MD 1107 - Active devices for disinfection and sterilisation
*MD 1301 - Monitoring devices of non-vital physiological parameters
*MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable medical devices
*MD 0403 - Dental implants
*MD 0302 - Suture material and clamps
*MD 1112 - Medical gas supply systems and parts thereof
*MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia