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DECLARATION OF CONFORMITY TO 93/42/EEC

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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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