Technical Information; Manufacturer; Declaration Of Conformity - I-Tech PHYSIO 4 User Manual

Manufacturer

Via S. Pertini, 24/a • 30030 Martellago (VE)
IACER S.r.l. is an Italian manufacturer of medical devices (
0068/QCO-DM/234-2020
S.r.l.)

Declaration of conformity

Via S.Pertini 24/A – 30030 Martellago (Ve), Italy
declares under its own responsibility that the product
UMDNS Code: 11503 e 11474 (respectively)
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:
Certificate no.: 0068/QCO-DM/234-2020
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.
Tel. 041.5401356 • Fax 041.5402684
from the Notified Body
I.A.C.E.R. S.r.l
I-TECH PHYSIO 4
I-TECH PHYSIO EMG
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123

Technical information

n°0068 MTIC InterCert
MASSIMO MARCON
_____________________
Legal Representative
1
certified CE n°
MNPG178