CE Certificate - Custom Biogenic Systems
CE Certificate - Custom Biogenic Systems
CE Certificate - Custom Biogenic Systems
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EC <strong>Certificate</strong> - Production Quality AssuranceDirective 93/42/EEC on Medical Devices, Annex VNo. <strong>CE</strong> 95520Issued To:<strong>Custom</strong> <strong>Biogenic</strong> <strong>Systems</strong>74100 Van Dyke RoadBruce TownshipRomeoMichigan48065USAIn respect of:The manufacture of cryogenic preservation storage systems.on the basis of our examination of the quality assurance system under the requirements of Council Directive93/42/EEC, Annex V. The quality assurance system meets the requirements of the directive. For the placing on themarket of class IIb and class III products an Annex III certificate is requiredFor and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086):Gary Fenton, Global Assurance DirectorFirst Issued: 23 September 2005 Date: 25 June 2014 Expiry Date: 22 September 2015Page 1 of 1Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the requiredsurveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the companynamed 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 9000BSI 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.
EC <strong>Certificate</strong> - Production Quality Assurance<strong>Certificate</strong> History<strong>Certificate</strong> No: <strong>CE</strong> 95520Date: 25 June 2014Issued To:<strong>Custom</strong> <strong>Biogenic</strong> <strong>Systems</strong>74100 Van Dyke RoadBruce TownshipRomeoMichigan48065USADateReferenceNumber23 September 2005 First IssueAction08 June 2009 7336135 Re-Issue due to change of company address26 August 2010 7475401 <strong>Certificate</strong> renewalAddition of EMERGO EUROPE as the EU authorisedrepresentative25 June 2014 8163883 Change of legal manufacturer address from '<strong>Custom</strong> <strong>Biogenic</strong><strong>Systems</strong>, 150 Shafer Drive, Romeo, Michigan, 48065 USA' to'<strong>Custom</strong> <strong>Biogenic</strong> <strong>Systems</strong>, 74100 Van Dyke Road, BruceTownship, Romeo, Michigan, 48065, USA'Page 1 of 1Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the requiredsurveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the companynamed 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 9000BSI 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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