Declaration Of Conformity - DJO ARTROMOT-S4 Modo De Empleo

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,
the product is a device of risk class IIa.
0297
Freiburg, 15 April 2021
This certificate is valid until expiry of the certificate referred to.
(The certificate 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)
Notified body:
DQS Medizinprodukte GmbH
August-Schanz-Straße 21
6043 Frankfurt am Main, Germany
–––––––––––––––––––––––––––––––––––––––––
– QA Management Representative ARTROMOT –
–Bernhard Krohne–
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