COMUNICATO - Autorizzazione a Bureau Veritas Italia S.p.A., in Milano, al rilascio della certificazione CE di rispondenza della conformita' dei dispositivi medici. (13A08419)
Con decreto dirigenziale del Ministero della salute di concerto con il Ministero dello sviluppo economico, datato 27 settembre 2013 , l'organismo notificato Bureau Veritas Italia S.p.A., con sede legale in Milano via Miramare n. 15, e' stato autorizzato all'attivita' di certificazione, di cui alla direttiva 93/42/CEE, per le seguenti tipologie di dispositivi medici: ALLEGATI II, V e VI DISPOSITIVI MEDICI NON ATTIVI Dispositivi medici non attivi, non impiantabili, in generale: a) dispositivi non attivi per anestesia, emergenza e terapia intensiva;
b) dispositivi non attivi per iniezione, infusione, trasfusione e dialisi;
c) dispositivi non attivi per ortopedia e riabilitazione;
d) dispositivi non attivi per oftalmologia;
e) strumenti non attivi;
f) dispositivi medici non attivi per disinfettare, pulire e sciacquare. Dispositivi per la cura delle ferite: g) bende e medicazioni per ferite;
h) materiali per sutura e clamps;
i) altri dispositivi medici per la cura delle ferite. Dispositivi dentali non attivi ed accessori: j) strumenti e attrezzature dentali non attivi;
k) materiali dentali;
l) impianti dentali. DISPOSITIVI MEDICI ATTIVI (non impiantabili) Dispositivi medici attivi in generale: m) dispositivi per apparato respiratorio, dispositivi per ossigenoterapia , dispositivi per anestesia per inalazione (ad esclusione degli impianti per la distribuzione di gas medicali e di gas medicinali);
n) dispositivi per stimolazione o inibizione;
o) dispositivi attivi chirurgici;
p) dispositivi attivi dentali;
q) dispositivi attivi per la disinfezione e la sterilizzazione;
r) dispositivi attivi per riabilitazione e protesi...
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