I-Tech MAG2000, Руководство пользователя

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I.A.C.E.R. Srl 5 MNPG52-04
Technical
Specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. +39 0415401356 • Fax +39 0415402684
www.itechmedicaldivision.com • iacer@iacer.it
IACER S.r.l. is an Italian medical devices manufacturer (CE medical
certificate n° MED24021 issued by Cermet notified body n° 0476).
Declaration of conformity
IACER S.r.l., headquartered in Italy, via S. Pertini 24/A 30030
Martellago (VE), declares on its own responsibility that MAG2000 is
manufactured in conformity with 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.
Certification Path: Annex II.
MAG2000 is a Class IIa equipment, with reference to Directive
93/42/EEC (MDD), annex IX rule 9 (and following modifications).
Martellago, 03/06/10 Legal Representative
Mario Caprara