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EC Declaration of Conformity
QAL Medical LLC. declares that the following Continuous Passive Motion (CPM)
medical devices have been classified as Class IIa (Annex IX Rule 9) and are in
conformity with the essential requirements and provisions of Council Directive
93/42/EEC as amended by Directive 2007/47/EC:
6000G – Hand CPM
(Marked ORMED ARTROMOT®-F)
W2G – Wrist CPM
(Marked ORMED ARTROMOT®-H)
0120
The above devices are identical to QAL Medical products 6000 and W2
respectively, except for the labeling.
The EU Authorized Representative for QAL Medical LLC. is:
RSQR Ltd., Ludgate House, 107-111 Fleet Street, London EC4A 2AB
[email protected], www.rsqa.co.uk
The devices are subject to the procedure set out in Annex II of Directive
93/42/EEC as amended by Directive 2007/47/EC under the supervision of
Notified Body Number 0120, SGS United Kingdom, Ltd., Unit 202B, Worle
Parkway, Weston-Super-Mare, North Somerset, BS22 6WA, United Kingdom
Marinette, Wisconsin USA
October 10, 2011
QAL Medical LLC.
A division of
Quality Assembly and Logistics, LLC
Registered to ISO 13485 for Quality Assurance
3000 Woleske Road
Marinette, Wisconsin 54143 USA
Tel. 715.735.4700; 888.430.1625 Fax 715.732.6402
www.QALmedical.com
Susan Johnson
Regulatory Compliance
MOT-301-DE_USA-GB_Rev_03-04-01-2017_DV3.indd 36
17.01.17 10:10
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