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49
Declaration of conformity
In compliance with the Council Directive 93/42/EEC of 14 June 1993
concerning medical devices, the company
ORMED GmbH
Merzhauser Strasse 112
D-79100 Freiburg
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.
With reference to Rule 9 of the Directive 93/42/EEC, these products are devices
of risk class IIa.
Freiburg, March 15th 2010
- QA Management Representative-
This certificate is valid through: September 1st 2011
Annex:
ARTROMOT
®
-S2
PRO
ARTROMOT
®
-S3
ARTROMOT
®
-S3 Comfort
ARTROMOT
®
-K1
ARTROMOT
®
-K2
ARTROMOT
®
-K2
PRO
ARTROMOT
®
-K2
PRO
Chip
ARTROMOT
®
-K3
ARTROMOT
®
-K4
ARTROMOT
®
-SP2
ARTROMOT
®
-SP3
ARTROMOT
®
-E2
ARTROMOT
®
-E2 compact
D
E
C
L
A
R
A
T
IO
N
O
F
C
O
N
F
O
R
M
IT
IY
0297
www.performancehealth.fr
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