Declaration Of Conformity - DJO Global ARTROMOT-E2 Manual De Instrucciones

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
declares that the products of the product line
ARTROMOT® (see Annex)
fulill 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.
notiied body:
dQs Medizinprodukte Gmbh
0297
August-schanz-straße 21
60433 Frankfurt am Main
Freiburg, 04 March 2012
–––––––––––––––––––––––––––––––––––––––––
- QA Management Representative -
-Bernhard Krohne-
This certiicate is valid until expiry of the certiicate referred to.
(the certiicate can be downloaded from: https://de.dqs-ul.com/kunden/kundendatenbank.html)
Annex:
ARTROMOT®-s2PRO
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
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