User Manual

SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 42 / 47
ANNEXES
DECLARATION OF CONFORMITY
srl
MEDICAL INTERNATIONAL RESEARCH
Via del Maggiolino, 125 00155 - Roma - ITALIA
Declaration of EC Conformity
Quality Management System according to the requirements of Annex II of the Medical Device Directive 93/42/EEC.
Notified body CERMET N° 0476 - Certificate of Conformity N° 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 spirolab III
Classification IIa
This device is marked with
Any modifications to the Device which are not authorised by us will invalidate this declaration.
Roma …/ …. / 2006
Signature: Signature:
Simon Fowler Carmine Cerullo
Sales Manager Quality Manager