Ce Conformity Declaration - Ormesa 425 WORKING TABLE Use And Maintenance Handbook

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
medical devices Directive 93/42/EEC and subsequent amendments and additions,
according to which this device is class 1 and has been designed in observance of the
following standards:
CEI EN ISO 14971:2012
EN 12182:2012
EN 1041:2013
ISO 9999:2016
Foligno, 20/02/2017
425 school & free time table
Medical Devices - Application of
risk management to medical
devices
Technical aids for disabled persons
- general requirements and test
methods
Information supplied by the
manufacture with medical devices
Technical aids for persons with
disabilities - classification and
terminology
Pag. 5/17
The Legal Representative
Luigi Menichini