MIROxi
User Manual cod. 980265
Rev 1.6
Page 26 of 32
srl MEDICAL INTERNATIONAL RESEARCH
Via del Maggiolino 125, 00155 Roma - ITALY
Declaration of CE Conformity
Quality Management System according to the requirements of Annex II of the Medical Device Directive 93/42/EEC
implemented by the Legislative Decree 46 dated 24/02/97
Notified Body
CERMET No. 0476 -
Certificate
No. MED – 9826
MIR srl Medical International Research, declares that the Device subject of this declaration together with its
standard accessories conforms to the requirements of the Council Directive 93/42/EEC Annex I.
Device Description
Oximeter
Device Name
MIROxi
Classification
IIa
This Device is marked
Any modifications to the Device which are not authorised by MIR will invalidate this Declaration
Rome
06/10/2008
Paolo Sacco Boschetti
Chiarman
Rev.1 – Mod. PO-10DDC_
MIROxi
