spirobank G
User Manual cod. 980026
Rev 2.0
Page 40 of 46
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
Spirometer
Device Name
spirobank G
Classification
IIa
This Device is marked
Any modifications to the Device which are not authorised by MIR will invalidate this
Declaration
Rome 01 / 01/ 2007
Simon
Fowler
Carmine
Cerullo
Sales
Manager
Quality
Manager
Rev.0 – Mod. PO-10DDC_
spirobank G