Technical Information; Declaration Of Conformity - I-Tech MIO-IONOTENS User Manual

Manufacturer
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

Via Enzo Ferrari, 2 – 30037 Scorzè (Ve), Italia
herewith declares under its own responsibility, that the product
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
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
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.
Scorzè, 31/01/2022
___________________
Place, date
IACER Srl
I.A.C.E.R. S.r.l.
Via Enzo Ferrari, 2 • 30037 Scorzè (VE)
Tel. 041.5401356 • Fax 041.5402684
I.A.C.E.R. S.r.l
MIO-IONOTENS
UMDNS Code: 13762
2007/47/EC
0068 – MTIC InterCert S.r.l.

Technical information

(D.Lgs.37/2010)
MASSIMO MARCON
_____________________
Legal Representative
5
and further
MNPG151-08