Ec Declaration Of Conformity - wissner-bosserhoff Carisma Manual De Instrucciones

28. EC DECLARATION OF CONFORMITY

EC DECLARATION OF CONFORMITY
in accordance with the EC Directive for Medical Devices 93/42/EEC, appendix VII
The
manufacturer
Address:
hereby legally binding declares that the product:
Product description:
corresponds with the relevant provisions of the standard 93/42/EEC on medical products.
Above all, the named product has been certified in terms of fulfilling the "basic requirements" according to
Hereby, the requirements of the German Law on Medical Products (MPG) for labelling
The product was manufactured and tested conforming to the quality management system
ISO 9001:2008 and EN ISO 13485:2003+AC:2007 for medical products.
The conformity of the quality management system is certified by:
the TÜV Rheinland Product Safety GmbH certification office
If the product is manipulated without our prior permission, this certificate is no longer valid.
Wickede, Germany, 11/10/2010
Place, date:
This statement of conformity is valid in connection with the release document for the respective batch of produced devices.
Page 102
wissner-bosserhoff GmbH
Hauptstraße 4-6
D-58739 Wickede (Ruhr),
Germany
Nursing home bed „carisma"
Mod No.: 10-513; 10-0520
Medical product of class I
appendix I of the standard 93/42/EEC
for medical products.
have been fulfilled.
in accordance with
Approval certificate No. 01 100 3177
Approval certificate No. SX60026964 0001
Bernd W. Weber
(executive director)
Phone: 02377 / 784-0
Fax: 02377 / 784-166
E-mail: zentrale@wi-bo.de
Web: www.wi-bo.de