UFSK-International OSYS GmbH
Kirchhoffstraße 1
93055 Regensburg
Manual_500 ECO_SN0001-following_0520
www.ufsk-osys.com
Appendix
Appendix
EC
Declaration of Conformity
We, the company
UFSK-International
OSYS
GmbH
Kirchhoffstraße 1
93055
Regensburg
Germany
declare and represent on our own responsibility, that
the following product
Treatment chair 500 ECO
(including accessories)
Category:
Treatment chair, active (electrical)
Basic-UDI-DI:
4057027TC001LG
Product
name:
500
ECO
Product code Item No. (REF)
15000008
Classification Medical Device:
Class I, non-sterile and without measuring function
(inc. accessories according annex)
to which this declaration refers is in due compliance with:
• Conformity assessment procedure in accordance with Annexes II and II -
Regulation (EU) 2017/745, Art. 52 (7)
• Conformity assessment procedure: Appendix VII
Council Directive 93/42/EEC of 14 June 1993 (Medical Device Directive) – superseded on 26 May 2021
• Council Directive 2011/65/EEC of 08 June 2011 Restriction of Hazardous Substances Directive (RoHS)
• Technical standards:
- EN 60601-1:2006/A1:2013
- EN 60601-1-2:2015
UFSK-International OSYS GmbH
Regensburg, 09.06.2020
Jürgen Scherrieble - General Manager
( signatory in block letters and responsible position of the signatory)
Attention
In case of unauthorized modifications or alterations to the product without proof of the manufacturer’s prior
express consent the present declaration will become null and void.
