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

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1 Notification of a Body in the framework of a technical harmonization directive From : Ministero dello Sviluppo Economico - Direzione Generale per il Mercato, la Concorrenza, il Consumatore, la Vigilanza e la Normativa Tecnica Via Sallustiana, ROMA Italy To : European Commission GROWTH Directorate-General 200 Rue de la Loi, B-1049 Brussels. Other Member States Reference : Legislation : 93/42/EEC Medical Body name, address, telephone, fax, , website : TUV Rheinland Italia SRL Via Mattei, Pogliano Milanese (MI) Italy Phone : Fax : info@it.tuv.com Website : Body : NB 1936 Created : 23/07/2007 Last update : 23/04/2015 Period of validity of the notification : Valid until : 08/01/2018 The body is assessed according to : - EN EN ISO/IEC Certification of products - EN EN ISO/IEC Certification of management systems - EN EN ISO/IEC Testing and calibration laboratories - Direttiva 93/42/CEE - D.LGS N. 46/97 - NBOG'S BEST PRACTICE GUIDES - MEDDEV Designating Authorities Handbook The competence of the body was assessed by : MINISTERO DELLA SALUTE The assessment of the body covers the product categories and conformity assessment procedures concerned by this notification : Yes 1 / 5

2 Tasks performed by the Body : Created : 16/09/2014 Last update : 16/09/2014 *MD General non-active, non-implantable medical - *MD Non-active for anaesthesia, emergency and intensive care - *MD Non-active for injection, infusion, transfusion and dialysis - *MD Non-active orthopaedic and rehabilitation - *MD Non-active medical with measuring function - *MD Non-active ophthalmologic - *MD Non-active instruments - *MD Contraceptive medical - *MD Non-active medical for disinfecting, cleaning, rinsing *MD Devices for wound care - *MD Bandages and wound dressings - *MD Suture material and clamps - *MD Other medical for wound care I I I I I I I I I I - Excluding Non-active for transfusion and dialysis 2 / 5

3 *MD Non-active dental and accessories - *MD Non-active dental equipment and instruments - *MD Dental materials - *MD Dental implants *MD General active medical - *MD Devices for extra-corporal circulation, infusion and haemopheresis - *MD Respiratory, including hyperbaric chambers for oxygen therapy, inhalation anaesthesia - *MD Devices for stimulation or inhibition - *MD Active surgical - *MD Active ophthalmologic - *MD Active dental I I I I I I I I I I I I I and hyperbaric chambers for oxygen therapy 3 / 5

4 - *MD Active for disinfection and sterilisation - *MD Active rehabilitation and active prostheses - *MD Active for patient positioning and transport - *MD Software *MD Devices for imaging - *MD Imaging utilising ionizing radiation - *MD Imaging utilising non-ionizing radiation *MD Monitoring - *MD Monitoring of non-vital physiological parameters - *MD Monitoring of vital physiological parameters *MD Devices for radiation therapy and thermo therapy - *MD Devices utilising ionizing radiation I I I I I I I I I I I 4 / 5

5 - *MD Devices utilising non-ionizing radiation - *MD Devices for hyperthermia / hypothermia - *MD Devices for (extracorporal) shock-wave therapy (lithotripsy) I I I Horizontal technical competence *MDS Medical in sterile condition 5 / 5

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