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DÉCLARATION de CONFORMITÉ
ORMESA S.r.l. GUARANTEES AND DECLARES, under its own exclusive
responsibility, that the following medical device, technical aid for
Which this declaration refers to, conforms with the general requirements provided
in the Directive 93/42/EEC and subsequent amendments and additions, concerning
the medical devices, according to which this aid belongs to the risk class I and has
been designed in observance to the following standards:
CEI EN ISO 14971:2012
EN 12182:2012
ISO 9999:2011
EN 1041:2009
EN 1985 :2000
EN ISO ISO 11199-3:2005
EN UNI EN ISO11199-2:2005 Walking aids manipulated by both arms.
October 14, 2014
rehabilitation:
GRILLO MINI
Anterior/Posterior Gait Trainer
Medical Devices - Application of risk
management to medical
technical aids for disabled persons - general
requirements and test methods
Technical aids for persons with disabilities -
Classification and terminology
Information supplied by the manufacture with
medical devices
Walking aids. General requirements and test
methods
Walking aids manipulated by both arms -
Requirements and test methods – Part 3:
Walking tables
Requirements and test methods. Rollators
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the Legal Representative
Luigi Menichini
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