Declaration Of Conformity - Prism Medical UK FREEWAY SA160 User Manual

DECLARATION OF CONFORMITY

Manufacturers Name:
MHRA Registration No:
Manufacturers Address:
Declares that the manufactured product:-
Product Name:
Model Number (S):
Product Options:
Conforms to the following European Union Council Directives:-
Directive 93/42/EEC and all amendments up to Directive 2007/47/EC
Classification Class 1, Low Risk Medical Device
Tested in accordance with BS EN ISO 10535:2006 & IEC 60601 3rd Edition
Directive 89/336/EEC for Electromagnetic Compatibility
Supplementary Information:
The undersigned declares the product herewith complies with the requirements set out
above and carries the CE mark accordingly.
The Technical Construction File required by this directive is maintained by the
manufacturer as detailed above.
Signed:
Craig Wright, Manufacturing Director
SA160 User Manual
Prism Medical UK Ltd
CA 013248
Units 1-4, Tir Llwyd Industrial Estate,
Kinmel Bay, Conwy,
LL18 5JA, UK
Tel +44 (0) 844 980 2296
Fax +44 (0) 844 980 2297
Prism Medical UK— Stand Aid
SA160
160 Kg
Date:
Rev 5—October 2016
14th November 2014
Page 19