Anda di halaman 1dari 1

zimmer

--. .

. .
EC Declaration of Conformity
Manufacturers Name: Zimmer GmbH

: Sulzer Allee 8
CH - 8404 Winterthur
Switzerland

~lloclassic"~ w e ~ m i i l l e rSLL,
" ~ ~ SL-HAC,
, SLV, SLO
Hip Stems
-
SL: 2839; 2840; 2841; 2842; 2843; 2844; 2845; 2846; 2847; 2848; 2849;
2850; 2851; 2852

-
SLL: 2883; 2884; 2885; 2886; 2887; 2888; 2889; 2890; 2891

-- SL-HAC: 2861; 2862; 2863; 2864; 2865; 2866; 2867; 2868; 2869; 2870;
-
T

2871; 2872

-
SLV: 01.00125.001; 01.00125.000; 01.00125.010; 01.00125.020;
01.00125.030; 01.00125.040; 01.00125.050; 01.00125.060; 01.00125.070;
01.00125.080; 01.00125.090; 01.00125.100; 01.00125.110; 01.00125.120

-
SLO: 01.00121.001; 01.00121.000; 01.00121.010; 01.00121.020;
01.00121.030; 01.00121.040; 01.00121.050; 01.00121.060; 01.00121.070;
01.00121.080; 01.00121.090; 01.00121.100; 01.00121.110 ; 01.00121.120

ion: Class: Ill

Conformity Assessment Zimmer GmbH uses the following procedures for the CE-labeling of
Route: their products according the Directive 93/42 (EEC):
Class Ill: EC Conformity Declaration according to Appendix 11.3 + 11.4
EC Design Examination Certificate No: CE 518195
GMDN Code (If applicable) 35666

Notified Body: BSI PRODUCT SERVICES


Identification Number: CE 0086
We hereby declare that the medical device(s) specified above meet the provisions of the Council
Directive No. 93142lEEC for Medical Devices. This declaration is supported by the Quality System
approval to I S 0 13485 and particular requirements for the application of EN I S 0 9001 issued by BSI
Product Services.
All supporting documentation is retained at the premises of the manufacturer.

Daniel Buehler
Vice President Quality & Regulatory Affairs, EMEA Date (dd.mm.yyyy)

Form: AAU Q.01.270e Rev. 9 Document:. 107812 Rev. 00


SAP Template 95655-000-01 Page: 1 of1