Technical Information; Manufacturer; Declaration Of Conformity - I-Tech MIO-SONIC Benutzerhandbuch

Manufacturer

IACER Srl. is an Italian manufacturer of medical devices (certified CE n°
0068/QCO-DM/235-2020 from the Notified Body n° 0068 MTIC InterCert
S.r.l.).

Declaration of conformity

Via S.Pertini 24/A – 30030 Martellago (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 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
Compliance of the concerned product with the Directive 93/42/EEC has been
assessed and certified by the Notified Body:
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
________________
Martellago, 03/08/2020
Place, date
IACER Srl
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. 041.5401356 • Fax 041.5402684
I.A.C.E.R. S.r.l
MIO-SONIC
UMDNS Code: 11248
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123
Certified number: 0068/QCO-DM/235-2020

Technical Information

_____________________
MASSIMO MARCON
Legal Representative
29 MNPG71-04