Technical Specification; Manufacturer; Declaration Of Conformity - I-Tech MAG3000 User Manual

Manufacturer

Via S. Pertini, 24/a • 30030 Martellago (VE)
IACER S.r.l. is an Italian manufacturer of medical devices (CE
certificate No. issued by the Notified Body No. 1936 TÜV Rheinland
Italia srl).

Declaration of conformity

IACER S.r.l., with registered office in via S. Pertini 24/A 30030
Martellago (VE), declares that the MAG3000 device complies with the
essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices (Leg. Decree46/97 of 24 February 1997
"Implementation of Directive 93/42/EEC concerning medical devices"),
Annex II as amended by Directive 2007/47/EC of 5 September 2007
(Leg. Decree37/2010 of 25 January 2010).
Notified body:TÜV Rheinland Italia srl, Via Mattei 3 - 20010 Pogliano
Milanese (MI) Italy.
Certification path:Annex II, excluding item 4.
The MAG3000 device is a class IIa equipment according to Annex IX,
rule 9 of Directive 93/42/EEC (and subsequent amendments).
Martellago, 12/06/19
I.A.C.E.R. Srl
I.A.C.E.R. S.r.l.
Tel. 041.5401356 • Fax 041.5402684
Technical
specification
The legal representative
Massimo Marcon
5 MNPG273-00