APPARECCHIATURE ELETTROMEDICALI SCIENTIFICHE OSPEDALIERE MEDICAL DEVICES FOR RESPIRATORY CARE DECLARATION OF CONFORMITY TO 93/42/EEC DIRECTIVE CONCERNING MEDICAL DEVICES Model names: PEGASO COUGH PEGASO A-COUGH PEGASO COUGH PERC PEGASO A-COUGH PERC (230, 230-S, 115, 115-S) (230, 230-S, 115, 115-S) (230, 230-S, 115, 115-S) (230, 230-S, 115, 115-S) CE Mark: Comply with the requirements of EC Directive 93/42/EEC + A2007 annex II, 3. Manufacturer: Dima Italia Srl Address of manufacturer: Via Vighi, 29 40133 Bologna - Italy Product type: Positive and negative pressure pulmonary ventilators. Safety standards: IEC EN 60601-1:2005, IEC EN 60601-1-2:2007 IEC 62304:2006 ISO 14971:2012, ISO 10993-1:2009, ISO 9703-3:2000 ISO 9919:2009 Risk class: II B The undersigned declares that these products comply with the Standards stated above and meet the general requirements of EC Directive 93/42/EEC + A2007 annex II, 3 as reported on the certificate n. MED 9932 released by the European Notified Body n. 0476 CERMET. Bologna, December 18th, 2014 DIMA ITALIA SRL Vito Didonna General manager DIMA ITALIA SRL – Via C. Vighi, 29 – 40133 Bologna – Italy Tel. ++39.051.56.88.57 Fax ++39.051.56.39.94 e-mail: [email protected] – www.dimaitalia.com Cod. Fisc./Part. IVA/Iscriz. Reg. Imprese 04219620376 – N. REA 356439 – Capitale Sociale inter. vers. € 18.000,00
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