Etiquetas Y Placas; Declaratión Ce - Ormesa STANDY 3 Manual De Uso

ETIQUETAS Y PLACAS

Nombre del modelo
Código lote
DECLARATIÓN
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:
CEI EN ISO 14971:2012
EN 12182:2012
EN 1041:20 13
ISO 9999:2011
CEI EN 980:2009
September 13th, 2017
Número de serie
Via A. Da Sangallo, 1 06034 Foligno (PG) ITALY Tel. +39 074222927 Fax +39 074222637
M O D E L .
S N
LOT
Fecha de
fabricación
STANDY 3 and STANDY 4
STANDING FRAMES FOR AN UPRIGHT POSITION
Medical Devices - Application of risk management
to medical
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
Symbols for use in the labelling of medical
devices
Número del artículo
P A R T N °
MAX. KG
!
Atención!!
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7/45
®
s.r.l.
Peso máximo admisible
Conformidad a los requisitos
de seguridad de la Unión
Europea