Cosmed microQuark - Dichiarazione DI Conformità

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 Declaration of conformity

Manufacturer: COSMED S.r.l.

Address: Via dei Piani di Monte Savello 37

00041 Albano Laziale (RM)

ITALY

hone: +39-06-9315492

fax: +39-06-9314580

manufacturer of the following equipment:

microQuark

declares under his sole responsibility that:

• the above listed equipment comply with the essential requirements of the Annex I of the Medical Device Directive 93/42/EEC;

• are classified in Class IIa;

• their design, manufacturing and final checks are performed according the Cosmed’s Quality System, conform to ISO 9001:2008 and

ISO13485:2003 Norms, certified by CERMET (certificates nr. 387-A and 387-M);

• are CE marked according to the Medical Device Directive 93/42/EEC and certified by CERMET (certificate nr. MED 9811).

The equipment conform with the following specifications:

Safety: IEC 60601-1

EMC: IEC 60601-1-2

32 - Appendix - Dichiarazione di conformità