Certification - progeo EXELLE User Manual

11.0 Certification

Declaration of conformity CE
The manufacturer REHATEAM s.r.l.
premises in Vicolo Negrelli, 4 – 31040 Castagnole di Paese (TV) Italia
declares that the product defined as
WHEELCHAIR FOR DISABLED PERSONS , PROGEO series, model:
which this declaration refers to,
is in conformity with the guidelines as laid down by European Union
Directive 2007/47/CE
applied in Italy as D.L.gs 37/2010.
the manufacturer has classified the above mentioned product as
CLASS I Medical Device
based on provisions as set out in the addendum IX of EU Directive 93/42
made in compliance with rule UNI EN 12183-2009
•
UNI CEI EN ISO 14971:2008
•
UNI EN 980:2002
•
UNI EN 1041 :2001
Castagnole di Paese (TV)
30/03/2010
EXELLE
EXELLE 51