EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
No.
CE 610850
Issued To:
GlySure Limited Units 4-6 The Quadrant Abingdon Science Park Abingdon Oxfordshire OX14 3YS United Kingdom
In respect of:
The design and manufacture of a Continuous Intravascular Glucose Monitoring System. The design and manufacture of Central Venous Catheter Sets.
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):
Frank Lee, EMEA Compliance & Risk Director First Issued: 05 February 2015
Date: 30 June 2015
Expiry Date: 04 February 2020
Page 1 of 1 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.
EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No:
CE 610850
Date:
30 June 2015
Issued To:
GlySure Limited Units 4-6 The Quadrant Abingdon Science Park Abingdon Oxfordshire OX14 3YS United Kingdom
Subcontractor:
Service(s) supplied
Arrotek Medical Limited Collooney Business Park Collooney Sligo Ireland
Manufacture
Contract Medical International, GmbH Lauensteiner Strasse 37 01277 Dresden Germany
Manufacture
Contract Medical International Spol. S.r.o Vazni 848 Hradec Kralove 500 03 Czech Republic
Manufacture
Page 1 of 4 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.
EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No:
CE 610850
Date:
30 June 2015
Issued To:
GlySure Limited Units 4-6 The Quadrant Abingdon Science Park Abingdon Oxfordshire OX14 3YS United Kingdom
Subcontractor:
Service(s) supplied
Ebster CZ sro Sterilisation and Laboratory Facilities Prumyslová zóna Kosíkov 80 Velká Bítes 595 01 Czech Republic
Sterilization
GlySure Limited Unit 1 The Quadrant Abingdon Science Park Abingdon Oxfordshire OX14 3YS United Kingdom
Manufacture
Oxford Scientific Software 14 Quarry Road Headington Oxford OX3 8NU United Kingdom
Software
Page 2 of 4 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.
EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No:
CE 610850
Date:
30 June 2015
Issued To:
GlySure Limited Units 4-6 The Quadrant Abingdon Science Park Abingdon Oxfordshire OX14 3YS United Kingdom
Subcontractor:
Service(s) supplied
Protek Medical Finisklin Business Park, Sligo Co. Sligo Ireland
Manufacture
Sascal Displays Ltd Unit 16, The Metro Centre Springfield Road Hayes Greater London UB4 0LE United Kingdom
Manufacture
Synergy Health Sterilisation UK Ltd (Synergy Health - AST - Swindon) Moray Road Elgin Industrial Estate Swindon SN2 8XS United Kingdom
Gamma Sterilization
Page 3 of 4 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.
EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No:
CE 610850
Date:
30 June 2015
Issued To:
GlySure Limited Units 4-6 The Quadrant Abingdon Science Park Abingdon Oxfordshire OX14 3YS United Kingdom
Subcontractor:
Service(s) supplied
Synergy Health Sterilisation UK Ltd (Synergy Health - AST - Thorne) 1 Alpha Court Capitol Park Thorne, Doncaster DN8 5TZ United Kingdom
ETO Sterilization
Page 4 of 4 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.
EC Certificate - Full Quality Assurance System Certificate History Certificate No:
CE 610850
Date:
30 June 2015
Issued To:
GlySure Limited Units 4-6 The Quadrant Abingdon Science Park Abingdon Oxfordshire OX14 3YS United Kingdom
Date
Reference Number
Action
05 February 2015
8109867
First issue
30 April 2015
8247878
Modification of scope for the inclusion of ‘Central Venous Catheter sets’. Addition of significant subcontractors for CVC Manufacture: ‘Contract Medical International, Hradec Kralove, Czech Republic’ and ‘Contract Medical International GmbH, Dresden, Germany’ Addition of significant subcontractor for CVC Sterilization: ‘Ebster CZ sro, Velká Bíteš, Czech Republic’ as significant subcontractors.
30 June 2015
8110026
Extension of scope of certificate to cover all parts of the Continuous Intravascular Glucose Monitoring System. Addition of significant subcontractors for sensor: ● Protek Medical (Finisklin Business Park, Sligo, Co. Sligo, Ireland) for the activity of ‘manufacture’. ● Arrotek Medical Ltd (Collooney Business Park, Dublin Rd, Collooney, Co. Sligo, Ireland) for the activity of ‘manufacture’. ● Synergy Health Sterilisation UK Ltd (Moray Road, Elgin Industrial Estate, Swindon, Wiltshire, SN2 8XS) for the activity of ‘Gamma Sterilization’ ● Synergy Health Sterilisation UK Ltd (Alpha Court, Capitol Park, Thorne, South Yorkshire, DN8 5TZ) for the activity of ‘ETO Sterilization’
Page 1 of 1 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.
