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DECLARATION OF CONFORMITY
Manufacturer: Precision Medical, Inc.
300 Held Drive, Northampton, PA 18067, USA
CONTACT: Quality Manager
Phone: 610-262-6090
Authorized European Representative:
Emergo Europe (European Ofce)
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570
Fax: +31 (0) 70.346.7299
Product: Gas Mixers for Medical Use (Blender)
Model(s):
PM5470EN, PM5480EN, PM5570EN, PM5580EN
MDD Class: IIb
Classication criteria: Clause 3.2 Rule 11 of Annex IX of MDD
As delivered, the object of the declaration described above is in conformity with the
requirements of MDD 93/42/EEC Annex II.3 and the following documents:
Document Edition
EN 980 2008
EN 1041 2008
ISO 11198 1995
ISO 14971 2007 2nd Ed
ISO 15001 2004
ISO 7000 2004
Notied Body: TÜV Rheinland Products Safety GmbH
EC Certicate No.: HD60019110 0001
www.precisionmedical.com
ISO 13485 Certied
505963 Rev3 (E) 04/05/10 Printed in USA