Authorized Representative - GENDEX 765DC Manuel De L'opérateur

Authorized Representative:

GENDEX Dental Systems s.r.l.
Via A, Manzoni 44
20095 Cusano Milanino - Mi
Tel: +39.02.61800.81
Fax: +39.02.61800.809
A. Name/Description of product:
Gendex 765DC Intraoral X-Ray System
REF: Model 110-0154G1,G2,G3
Class: IIb
B. Reference Standards under which conformity is declared:
IEC60601-1:1988 +A1:1991 +A2:1995
IEC60601-1-1:2000
IEC60601-1-2:2001
IEC60601-1-3:1994
IEC60601-1-4:1996
IEC60601-2-7:1998
C. GENDEX Dental Systems, Inc. declares that the products described
herein meet all the applicable Essential Requirements of the EC
Medical Device Directive 93/42/EEC in Annex I. For Class IIb products
described herein, the product is manufactured, inspected, tested, and
released in accordance with the approved quality assurance system
established in accordance with ISO 9001, EN 46001 and Annex II of the
EC Medical Device Directive under the supervision of the British
Standards Institution, a Notified Body carrying the Notified Body
No. 0086.
EC Declaration of Conformity
IEC60601-2-28:1993
IEC60601-2-32:1994
IEC60336:2005
IEC60417:1973
John R. Miller
Director of QA/RA
GENDEX Dental Systems
Printed on: 29 Mär 2012, 05:33:23 pm; Printed by: UWE.ZELLER
GENDEX Dental Systems
901 West Oakton Street
Des Plaines, IL 60018-1884
Tel: (847)640-4800
Fax (847)640-4891
765DC
IEC60522:2003
IEC60878:2003
EN 980:1997
ISO14971:2000
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