User's Manual

SmartOne
Page 14 of 17
Rev.0.1
User manual
MEDICAL INTERNATIONAL RESEARCH
Via del Maggiolino, 125 00155 - Roma - ITALY
DECLARATION OF CONFORMITY CE
(annex II excluding par.4)
We hereby declare that the following device:
Type Spirometer
Brandname MIR Medical International Research
Device name Smart One
®
Class IIa
Complies with the Essential Requirements of directive 93/42/EC concerning Medical Devices, and its
amendments, and its transposition in the Member States.
This statement is made on the basis of the CE Certificate n. MED 9826 issued by Cermet, Notified Body n.
0476.
Rome ……………….
Paolo Sacco Boschetti
The Chairman