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12.
Declaration of conformity
Declaration of conformity
In compliance with the Council Directive 93/42/EEC of 14 June 1993
concerning medical devices, the company
ORMED GmbH & Co.KG
Merzhauser Strase 112
D-79100 Freiburg, Germany
declares that the products of the product line
ARTROMOT
®
(see Annex)
fulfill the requirements of the Council Directive 93/42/EEC of 14 June
1993, Annex II as well as the essential requirements of Annex I.
0297
Freiburg, 13/06/2007
_______________________________________
- QA Management Representative -
Annex:
ARTROMOT
®
-S2PRO
ARTROMOT
®
-S3
ARTROMOT
®
-S3 Comfort
ARTROMOT
®
-K1
ARTROMOT
®
-K2
ARTROMOT
®
-K2PRO
ARTROMOT
®
-K2PRO Chip
ARTROMOT
®
-K3
ARTROMOT
®
-K4
ARTROMOT
®
-SP2
ARTROMOT
®
-SP3
ARTROMOT
®
-E2
ARTROMOT
®
-E2compact
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