DECLARATION OF CONFORMITY
Lojer Oy
Putajantie 42, P.O.Box 54
FIN-38201 Sastamala, Finland
declares that
LOJER 19100 Pulley, 19200 Speed Pulley, 19200M Mobile Pulley and
19300 Vertical Pull
are in conformity with the following essential requirements of the Directive 93/42/EEC (Medical Devices)
and the corresponding Finnish National Law no. 629 (2010).
The designing of these devices is based on the following harmonized standards:
EN ISO 14971:2009
Quality Management System: ISO 9001:2000
The products are marked with the CE marking
Sastamala, Finland 2012-09-01
LOJER OY
Aliina Tuomenlehti
Risk management engineer