Declaration Of Conformity - I-Tech MAG700 User Manual

Technical specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via Enzo Ferrari, 2 • 30037 Scorzè (VE)
Tel. 041.5401356 • Fax 041.5402684
IACER Srl is an Italian medical devices manufacturer (CE certificate
n°0068/QCO-DM/230-2020 issued by MTIC InterCert S.r.l. notified body
n°0068).

Declaration of conformity

I.A.C.E.R. S.r.l
Via Enzo Ferrari, 2 – 30037 Scorzè (Ve), Italia
herewith declares under its own responsibility, that the family product
MAG2000
which includes the following models
MAG700, MAG2000, MAG2000 Premium and MAG2000 PLUS
UMDNS Code: 12415
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as
modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations.
The products have been assigned to class IIa, according to Annex IX, rule 9
of the Directive 93/42/EEC (and further modifications/integrations) and
bear the mark
Compliance of the concerned products with the Directive 93/42/EEC has
been assessed and certified by the notified body:
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123
Certified number: 0068/QCO-DM/230-2020
following the certification procedure according to Annex II (excluding point
4) of the Directive 93/42/EEC.
Scorzè, 31/01/2022 MASSIMO MARCON
________________ _____________________
Place, date Legal Representative
IACER Srl 4 MNPG69-09