Conformity Declaration - Ormesa 220487 Manual De Uso Y Mantenimiento

CONFORMITY DECLARATION

ORMESA S.R.L. guarantees and declares, under its own exclusive responsibility,
that the following medical device, technical aid for rehabilitation:
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 I risk class and has been
designed in observance to the following standards:
UNI CEI EN ISO 14971:2020
UNI EN 12182:2012
ISO 9999:2017
UNI EN 1041:2013
UNI CEI EN ISO 15223-1:2017
UNI CEI EN ISO 13485:2016
MULTIFUNCTION TABLE
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Medical Devices - Application of risk
management to medical
Technical aids for disabled persons -
general requirements and test methods
Technical aids
disabilities -
terminology
Information supplied by the manufacture
with medical devices
Symbols for use in the medical device
labels, labeling and information to be
supplied - Part 1: General requirements
Medical devices
management systems Requirements
for regulatory purposes
Foligno 14/10/2020
for persons with
Classification
— Quality
and