DJO Global 80.00.023, Operating Instructions Manual

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85
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Declaration of conformity
In compliance with the Council Directive 93/42/EEC of 14 June 1993
about medical devices, the company
ORMED GmbH
Merzhauser Strasse 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.
With reference to Rule 9 of the Directive 93/42/EEC, the product is a
device of risk class IIa.
Notified body:
DQS Medizinprodukte GmbH
August-Schanz-Str. 21
60433 Frankfurt am Main, Germany
0297
Freiburg, 4. March 2012
–––––––––––––––––––––––––––––––––––––––––
- QA Management Representative -
-Bernhard Krohne-
This certificate is valid until expiry of the certificate referred to.
(the certificate can be downloaded from: https://de.dqs-ul.com/kunden/kundendatenbank.html))
Annex:
ARTROMOT®-S2 PRO
ARTROMOT®-S3
ARTROMOT®-S3 Comfort
ARTROMOT® ACTIVE-K
ARTROMOT®-K1
ARTROMOT®-K2
ARTROMOT®-K2PRO
ARTROMOT®-K2PRO Chip
ARTROMOT®-K3
ARTROMOT®-K4
ARTROMOT®-SP2
ARTROMOT®-SP3
ARTROMOT®-E2
ARTROMOT®-E2 compact