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 : ANSM : Agence Nationale de Sécurité du Médicament et des produits de santé - Direction de l'inspection 143, 147, Boulevard Anatole France SAINT-DENIS CEDEX France 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 : GMED 1, rue Gaston Boissier PARIS France Phone : Fax : info@lne-gmed.com Website : Body : NB 0459 The body is formally accredited against : EN EN ISO/IEC Name of National Accreditation Body (NAB) : COFRAC - Comité Français d'accréditation The accreditation covers the product categories and conformity assessment procedures concerned by this notification : Yes 1 / 6

2 Tasks performed by the Body : Last approval date : 03/08/2018 Product family, product /Intended use/product *MD General non-active, non-implantable medical devices - *MD Non-active devices for anaesthesia, emergency and intensive care Full quality assurance system - *MD Non-active devices for injection, infusion, Full quality assurance system transfusion and dialysis - *MD Non-active orthopaedic and rehabilitationfull quality assurance system devices - *MD Non-active medical devices with measuring function Full quality assurance system - *MD Non-active ophthalmologic devices Full quality assurance system - *MD Non-active instruments Full quality assurance system - *MD Contraceptive medical devices Full quality assurance system - *MD Non-active medical devices for disinfecting, cleaning, rinsing Full quality assurance system - *MD Non-active devices for in vitro fertilisationfull quality assurance system (IVF) and assisted reproductive technologies (ART) - *MD Non-active medical devices for ingestion *MD Non-active implants - *MD Non-active cardiovascular implants I I I I I I I I I I I 2 / 6

3 - *MD Non-active orthopaedic implants - *MD Non-active functional implants - *MD Non-active soft tissue implants *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 I I I I I I I I 3 / 6

4 - *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 ophthalmologic devices - *MD Active dental devices - *MD Active devices for disinfection and sterilisation I I I I I I I I 4 / 6

5 - *MD Active rehabilitation devices and active prostheses - *MD Active devices for patient positioning and transport - *MD Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART) - *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 I I I I I I I I 5 / 6

6 - *MD Monitoring devices of vital physiological parameters *MD Devices for radiation therapy and thermo therapy - *MD Devices utilising ionizing radiation - *MD Devices utilising non-ionizing radiation - *MD Devices for hyperthermia / hypothermia - *MD Devices for (extracorporal) shock-wave therapy (lithotripsy) I I I I I Horizontal technical competence *MDS Medical devices incorporating medicinal substances, according to Directive 2001/83/EC *MDS Medical devices utilising tissues of animal origin, including Regulation 722/2012 (Directive 2003/32/EC up to ) *MDS Medical devices referencing the Directive 2006/42/EC on machinery *MDS Medical devices in sterile condition Chemical sterilization/dry heat sterilization/hydrogen peroxid with or without plasma process sterilization/ultra High Temperature Infusion sterilization process *MDS Medical devices utilising micromechanics *MDS Medical devices utilising nanomaterials *MDS Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed *MDS Medical devices incorporating software /utilising software /controlled by software 6 / 6