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11.
-Declaration of Conformity
In compliance with the provisions of the Council Directive 93/42/EEC,
Annex II, of 14 June 1993 / Amendment of 5 September 2007,
concerning medical devices, the company
declares under its sole responsibility that the products of the product line
fulfill the essential requirements of Annex I
of the Council Directive 93/42/EEC.
With reference to Rule 9 of the Directive 93/42/EEC, Annex 9,
the product is a device of risk class IIa.
0297
Freiburg, 23 October 2020
This certifi cate is valid until expiry of the certifi cate referred to.
(The certifi cate for the year of manufacture can be downloaded from:
https://www.djoglobal.de/unternehmen/qualitaet-und-verantwortung)
Annex:
ARTROMOT®-S3
ARTROMOT®-S4
ARTROMOT® ACTIVE-K
ARTROMOT®-K1
ARTROMOT®-SP3
ARTROMOT®-E2
ORMED GmbH
Bötzinger Straße 90
D-79111 Freiburg
ARTROMOT® (see Annex)
Notifi ed body:
DQS Medizinprodukte GmbH
August-Schanz-Straße 21
60433 Frankfurt am Main
–––––––––––––––––––––––––––––––––––––––––
– QA Management Representative –
-Bernhard Krohne-
87
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