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EC DoC DOC2279611 Revolution Maxima

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25 views

EC DoC DOC2279611 Revolution Maxima

Uploaded by

Ala'a Ismail
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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GE Healthcare

DECLARATION OF CONFORMITY
Following the provisions of the Medical Devices Directive 93/42/EEC, Annex II
and of the directive 2011/65/EU.
We
Manufacturer EU Authorized Representative
GE Hangwei Medical Systems Co., Ltd. GE Medical Systems SCS
West Area of Building No.3, No.1 Yongchang North Road, 283 rue de la Minière
Beijing Economic and Technological Development Area, 78530 BUC, France
BEIJING 100176 CHINA

Manufacturing site
GE Hangwei Medical Systems Co., Ltd.
West Area of Building No.3, No.1 Yongchang North Road,
Beijing Economic and Technological Development Area,
BEIJING 100176 CHINA

Declare under our sole responsibility that the devices:


Revolution Maxima
X-Ray System, Diagnostic, Computed Tomography, Full-body
Ref: see CT parts identified in Product Configuration Master 5823529PCM
GMDN Code: 37618 UDI-DI: 00840682146180
Classification rule (93/42/EC Annex IX): 10 Class IIb
To which this declaration relates, is in conformity with the requirements of the Medical Devices Directive
93/42/EEC which apply to it and with the requirements of the directive 2011/65/EU on the restriction of the use of
certain hazardous substances in electrical and electronic equipment.

This conformity is based on the following elements:


• For the directive 93/42/EEC(MDD)
o Technical Documentation/DHF Ref./ réf: DOC2279121, of the product to which this declaration relates
o EC certificate: approval of full quality assurance system (Annex II of the directive 93/42 EEC) delivered by
G-MED (Notified Body # 0459), Certificate No.7848
o Harmonized standards applied on the product to which this declaration relates
• For the directive 2011/65/EU (RoHS)
o Technical Documentation/DHF Ref./ réf: DOC2279121, of the product to which this declaration relates
• List of harmonized standards applied for CE marking
EN 60601-1: 2006/A1: 2013 EN 60601-2-44: 2009/A2: 2016
EN 60601-1-2: 2015 EN 60601-1-6: 2010/A1:2015
EN 60601-1-3: 2008/A11: 2016 EN 62366: 2008/A1:2015
EN 62304: 2006/A1:2015 EN ISO 10993-1: 2009/AC:2010

Beijing, China Wang Xing


November-05-2019 Regulatory Affairs Manager

This EC declaration of conformity supersedes the previous declaration dated July 27, 2019.

Page 1 of 1 DOC2279611

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