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EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
No. CE 565719
Issued To:
Argon Medical Devices, Inc.
also trading as Becton Dickinson
Infusion Therapy Systems Inc.
1445 Flat Creek Road
Athens
Texas
75751
USA
In respect of:
The design and manufacture of single use instruments, catheters and
access devices for intravascular and non-vascular applications, biopsy
devices, fluid administration and pressure monitoring devices
on the basis of our examination of the quality assurance system under the requirements of Council Directive
93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For
the placing on the market of class III products an Annex II section 4 certificate is required.
For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086):
Gary Fenton, Global Assurance Director
First Issued: 28/02/2011 Date: 19/02/2014 Expiry Date: 01/12/2017
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Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000
BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.
A member of BSI Group of Companies.
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