I-Tech I-Press, Руководство пользователя

Страница: 5 / 32

IACER Srl 3 MNPG338-00
Technical information
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel.: +39 041.5401356 • Fax: +39 041.5402684
IACER S.r.l. is an Italian manufacturer of medical devices (CE certificate No.
HD60134521 issued by the Notified Body No. 1936 TÜV Rheinland Italia srl).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italy
declares under its own responsibility that the product
I-PRESS
UMDNS code : 10969
is designed and built in compliance with the essential requirements of
Annex 1 of Directive 93/42/EEC concerning medical devices
(implemented in Italy with Legislative Decree 46/97), as amended by
Directive 2007/47/EC (Legislative Decree 37/2010) and subsequent
amendments/additions.
The device is classified class IIa, according to Annex IX, rule 9 of Directive
93/42/EEC (and subsequent amendments/additions) and is marked
The conformity of the product in question with the Directive 93/42/EEC
has been verified and certified by the Notified Body:
1936 - TÜV Rheinland Italy
Via Enrico Mattei 3, 20010 Polignano Milanese (MI), Italy
Certificate No.:
HD60134521
according to the certification process provided for in Directive
93/42/EEC, Annex II (excluding point 4).
________________ _____________________
Place, date Legal representative
MASSIMO MARCON
Martellago, 31/07/2020