EN-54
DRAFT
R&TTE Declaration of Conformity (DoC)
We,
Name of company: Stryker Endoscopy
Address: 5900 Optical Court, San Jose, CA 95138
Authorized representative: Jean-Yves Carentz
Contact detail of authorized representative: Stryker France,
ZAC Satolas Green Pusignan, Av. de Satolas Green, 69881
MEYZIEU Cedex, France
Declare under our sole responsibility that the product:
Product name: Crossre2 Integrated Arthroscopy System
Trade Name: Crossre2 Console
Type or Model: 0475100000
Relevant Supplementary Information: None
to which this declaration relates is in conformity with the essential
requirements and other relevant requirements of the R&TTE Directive
(1999/5/EC).
e product is compliant with the following standards and/or other
normative documents:
Safety: EN 60601-1:1990+A1:1993+A2:1995+A13:1996
EMC: EN 60601-1-2:2007; EN 61000-3-2:2006
Radio Spectrum: EN 300 330-1 V1.5.1
Supplementary information: none
Notied body involved: TÜV Rheinland Product Safety
(GmbH)
Technical le held by: Stryker Endoscopy
Place and date of issue (of this DoC): San Jose, CA USA,
August 2009
Signed by or for the manufacturer:
Name: K. Jerey Semone
Title: Director, Regulatory Aairs
Hereby, Stryker Endoscopy declares that this Short Range Device is in
compliance with the essential requirements and other relevant provisions of
Directive 1999/5/EC.
To Next Page
Loading...
Need help?
General
