Declaration Of Conformity - DJO Global ARTROMOT-K1 Modo De Empleo

ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 70

Declaration of conformity

In compliance with the Council Directive 93/42/EEC of 14 June 1993
about medical devices, the company
declares that the products of the product line
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
0297
August-Schanz-Str. 21
60433 Frankfurt am Main, Germany
Freiburg, 4. March 2012
–––––––––––––––––––––––––––––––––––––––––
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®-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
ORMED GmbH
Merzhauser Strasse 112
D-79100 Freiburg - Germany
ARTROMOT® (see Annex)
- QA Management Representative -
- Bernhard Krohne -
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18.05.12 17:27