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Hersteller
IACER S.r.l. is an Italian medical devices manufacturer (CE medical certificate n° MED 24021).
Declaration of Conformity
IACER S.r.l., headquartered in Italy, via S. Pertini 24/A 30030 Martellago (VE), declares on its own
responsibility that MIO-IONOTENS is manufactured in conformity with Council Directive
93/42/EEC (MDD) dated 14 June 1993 (D. Lgs. 46/97 dated 24 February 1997 "Attuazione della
Direttiva 93/42/CEE concernente i dispositivi medici), Annex II as modified by Directive
2007/47/CE dated 5 September 2007 (D. Lgs 37/2010 dated 25 January 2010).
Notified Body: Cermet, Via di Cadriano 23 – 40057 Cadriano di Granarolo (BO) Italy.
MIO-IONOTENS is a Class IIa equipment, with reference to Directive 93/42/EEC (MDD),
annexed IX rule 9 (and following modifications).
Certification Path: Annex II
Martellago, 01/07/2014
Spezifikationen
MIO-IONOTENS has the following specifications:
•
Class IIa Gerät(Directive 93/42/EEC, annexed IX rule 9 und folgende
Modifikationen);
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Class II, Teileart BF (Classif. EN 60601-1);
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Nicht geschützt gegen das Eindringen von Flüssigkeiten;
•
Nicht geeignet für die Benutzung in Umgebungen mit enflammbaren Mitteln oder
hohem Sauerstoffgehalt ist untersagt.
IACER S.r.l.
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. 041.5401356 • Fax 041.5402684
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Konformitätserklärung
englisch
Legal representative
Mario Caprara
MNP151 Rev. 00 21/07/14
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