ISO 13485 and ISO 11135 - Sinapi Biomedical | Chest Drainage

Certificate GBl2l 85102
The management system of
Sinapi Biomedical (Pty) Ltd.
ARC lnfruitec North Campus, Lelie Road,
Stellenbosch, 7600, South Africa
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has been assessed and certifed as meeting the requirements of
ISO 13485:2003
EN ISO 13485 i2012
For the following activities
Design, manufacture and sales of sterile chest drainage systems and
urinary meters.
Manufacture of sterile and non-sterile single use scalpels,
Ethylene Oxide sterilisation in accordance with ISO 11135.
This certificate is valid from 01 March 2015 until0l March 2018 and
remains valid subject to satisfactory surveillance audits.
Re certification audit due before 27 October 2017
lssue 5. Certified since 01 March2012
Authorised by
ry
U KAS
MANACTMENT
SYSTEMS
o005
SGS United Kingdom
Ltd Systems & Services Certification
Rossmore Business Park Ellesmere Port Cheshire CH65 3EN UK
t +44 (0)15'1 350-6666 f +44 (0)151
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Certiflcatlon Seryices accessible al w.sgs.com/tems and conditions.hlm.
Atteniion is drawn to ihe limitations of liability, indemnification and juisdictional
issues established therein. The aulhenticity ofthis document may be verified at
httpJ/ww.sgs.@m/en/OuFCompany/Cedifi ed-Client-Directories/Certified-ClientDirectodes.aspx. Any unauthorized alteration, forgery or falsification
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