Notification of a Body in the framework of a technical harmonization directive

Transcription

1 Notification of a Body in the framework of a technical harmonization directive From : National Organization for Medicines (EOF) Mesogeion 284, Holargos Greece To : European Commission GROWTH Directorate-General 200 Rue de la Loi, B-1049 Brussels. Other Member States Reference : Legislation : 93/42/EEC Medical devices Body name, address, telephone, fax, , website : NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY Smyrnis GLYFADA Greece Phone : Fax : info@ekapty.gr Website : Body : NB 0653 Created : Unknown (Notifications pre-dating 2006 are not available in these lists) Last update : 12/07/2018 The body is formally accredited against : EN EN ISO/IEC EN EN ISO/IEC Name of National Accreditation Body (NAB) : ESYD The accreditation covers the product categories and conformity assessment procedures concerned by this notification : Yes 1 / 5

2 Tasks performed by the Body : Created : 29/11/2013 Last update : 11/11/2016 Product family, product /Intended use/product *MD General non-active, non-implantable medical devices - *MD Non-active devices for anaesthesia, emergency and intensive care - *MD Non-active devices for injection, infusion, transfusion and dialysis - *MD Non-active orthopaedic and rehabilitation devices - *MD Non-active medical devices with measuring function - *MD Non-active ophthalmologic devices - *MD Non-active instruments - *MD Contraceptive medical devices - *MD Non-active medical devices for disinfecting, cleaning, rinsing - *MD Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) *MD Non-active implants - *MD Non-active orthopaedic implants - *MD Non-active soft tissue implants 2 / 5

3 *MD Devices for wound care - *MD Bandages and wound dressings - *MD Suture material and clamps - *MD Other medical devices for wound care *MD Non-active dental devices and accessories - *MD Non-active dental equipment and instruments - *MD Dental materials - *MD Dental implants *MD General active medical devices - *MD Devices for extra-corporal circulation, infusion and haemopheresis - *MD Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia - *MD Devices for stimulation or inhibition - *MD Active surgical devices - *MD Active dental devices Respiratory devices only Only for physiotherapy 3 / 5

4 - *MD Active devices for disinfection and sterilisation - *MD Active rehabilitation devices and active prostheses - *MD Software - *MD Medical gas supply systems and parts thereof *MD Devices for imaging - *MD Imaging devices utilising ionizing radiation - *MD Imaging devices utilising non-ionizing radiation *MD Monitoring devices - *MD Monitoring devices of non-vital physiological parameters - *MD Monitoring devices of vital physiological parameters *MD Devices for radiation therapy and thermo therapy - *MD Devices utilising non-ionizing radiation - *MD Devices for hyperthermia / hypothermia - *MD Devices for (extracorporal) shock-wave therapy (lithotripsy) Only for physiotherapy 4 / 5

5 Horizontal technical competence *MDS Medical devices incorporating medicinal substances, according to Directive Only for MD Codes referred above 2001/83/EC *MDS Medical devices referencing the Directive 2006/42/EC on machinery Only for MD Codes referred above *MDS Medical devices in sterile condition Including aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, dry heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam) - Only for MD Codes referred above *MDS Medical devices incorporating software /utilising software /controlled by Only for MD Codes referred above software 5 / 5