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EC Certificate Production Quality Assurance System: Certificate GB10/81312

The management system of

Kiran Medical Systems Limited 0-134, T.T.C. Industrial Area, Shirvane, P.O. Nerul, Navi Mumbai, 400706, India has been assessed and certified as meeting the requirements of

Directive 93/42/EEC on medical devices, Annex V

For the following products

Sterile Radiation Protection Gloves, Sterile Radiation shield. For placing on the market of Class lib or Class III devices covered by this certificate, an EC Type Examination Certificate according to Annex III is required.

This certificate is valid from 12 September 2011 until 09 September 2015 and remains valid subject to satisfactory surveillance audits. Re certification audit due before 04 August 2013 Issue 2. Certified since 09 September 2010 Certification is based on reports numbered GB/PI 224645 oS

Authorised by

SGS United Kingdom Ltd, Notified Body 0120 202B Worle Parkway, Weston-super-Mare, B822 6WA UK f M (0)1934 522137 www.sgs.com

t M (0)1934 522917

8G8 CE 130311 Page 1 of 1

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