DJO 80.00.040, Руководство по эксплуатации

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11. -Declaration of Conformity
D
EC
LA
R
AT
ION
OF
C
ON
FOR
M
IT
Y
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
ORMED GmbH
Merzhauser Straße 112
D-79100 Freiburg
declares under its sole responsibility that the products of the product line
ARTROMOT® (see Annex)
fulfi ll 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.
Notifi ed body:
DQS Medizinprodukte GmbH
August-Schanz-Straße 21
60433 Frankfurt am Main
0297
Freiburg, 17 August 2018
–––––––––––––––––––––––––––––––––––––––––
– QA Management Representative –
-Bernhard Krohne-
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/arzt/qualitaet.html)
Annex:
ARTROMOT®-S3
ARTROMOT®-S4
ARTROMOT® ACTIVE-K
ARTROMOT®-K1
ARTROMOT®-SP3
ARTROMOT®-E2