IACER I-TECH MIO-IONOTENS, User Manual, Page: 51 / 232

IACER Srl 48 MNPG151-07
Technical information
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. 041.5401356 • Fax 041.5402684
IACER S.r.l. is an Italian manufacturer of medical devices (certified CE n°
0068/QCO-DM/234-2020 from the Notified Body n° 0068 MTIC InterCert S.r.l.).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italia
herewith declares under its own responsibility, that the product
MIO-IONOTENS
UMDNS Code : 13762
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 product has been assigned to class IIa, according to Annex IX, rule 9 of the
Directive 93/42/EEC (and further modifications/integrations) and bears the
mark
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123, Italia
Certified number: 0068/QCO-DM/234-2020
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
___________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Martellago, 03/08/2020