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DECLARATION OF CONFORMITY ELECTROMEDICAL EQUIPMENTS
Via Ugo La Malfa nr.31
43010 Pilastro (PR) ITALY
Tel. +39 0521 637133 - 631138 Fax. +39 0521 639041
P.IVA 00977090349
DECLARATION OF CONFORMITY
Manufacturer:
CA-MI snc
Address:
Via Ugo La Malfa n°31
Equipment:
Surgical aspirator
Trade name, model:
NEW HOSPIVAC 400 REF RE 310350
NEW HOSPIVAC 400 REF RE 310350/01
NEW HOSPIVAC 400 REF RE 310350/08
NEW HOSPIVAC 400 REF RE 310350/05
NEW HOSPIVAC 400 REF RE 310351
NEW HOSPIVAC 400 REF RE 310350/07
NEW HOSPIVAC 400 REF RE 310350/09
NEW HOSPIVAC 400 REF RE 310350/10
NEW HOSPIVAC 400 REF RE 310350/11
Intended purpose:
Surgical aspirator
to be used for the aspiration of the body liquids (mucus or catarrh and blood).
Ratings:
230V ~ / 50Hz 300VA
The above mentioned equipment is complying with the European Directives : Medical Devices Directive 93/42/EEC and
following updating
The above mentioned equipment is complying with the European Standards:
Safety Std: EN 60601-1
EMC Std: EN 60601-1-2 :2001
Other Std : EN ISO 10079-1
Addition Informations:
Mentioned equipment has been classified as Madical Device with risk class IIa accordino to the roles of Annex IX of 93/42/EEC Directive.
EC marking procedure has been carried out accordino to the provisions of Annex VII (Declaration of Conformità) and Annex V (EC
Declaration of conformità Production Quality Assurance) [Nemko AS Certificate no. EU0412402]
Notified Body:
NEMKO AS
Gaustadallèen 30
N-0371 Oslo Normay
Date of issue: mercoledì 8 marzo 2006
CA-MI snc
Il Legale Rappresentante L'Azienda
Mario Attolini
ISO 9001:2000 / ISO 13485:2003
CERTIFIED