EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex VNo.

CE 661328

Issued To:

Smiths Medical International Ltd.
Boundary RoadHytheKent
CT21 6JL
United Kingdom

In respect of:

See certificate scope page.

on the basis of our examination of the quality assurance system under the requirements of Council Directive
93/42/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 required.
For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086):

Stewart Brain, Head of Compliance & Risk Medical Devices
First Issued: 2017-06-28

Date: 2017-06-28

Expiry Date: 2022-06-27

Page 1 of 2
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: + 44 345 080 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.

Certificate No: CE 661328

Certificate Scope:
The manufacture and final inspection of sterile:
Drainage Devices, Obstetrics and Gynaecology Devices, Oxygen and Humidity ManagementDevices, Intubation Systems, Infusion Disposables, Feeding Devices Accessories
The manufacture and final inspection of non-sterile:
Resuscitation Devices, Tracheostomy Tubes, Intubation Systems
Those aspects of annex V relating to the securing and maintaining of sterility of VascularAccess Device Accessories, Infusion Disposables, Intubation Systems, Obstetrics andGynaecology Devices

First Issued: 2017-06-28

Date: 2017-06-28

Expiry Date: 2022-06-27

Page 2 of 2
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: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Brightwake Limited
Lowmoor Business Park
Kirkby-in-Ashfield
Nottinghamshire
NG17 7JZ
United Kingdom

Manufacture

GaleMed Corporation
No. 87, Li-Gong 2nd Road
Wu-JiaYILAN 268
TaiwanManufacture

GE MedicalPollards WoodNightingales Lane
Chalfont Saint Giles
HP8 4SP
United Kingdom

Manufacture

Page 1 of 9Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary RoadHytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Koo Medical Equipment (Shanghai)Co., Ltd
100 Zhongde Road
Dakun Industrial ParkSongjiang, Shanghai 201614
China

Manufacture

Pentair Filtration Solutions
1350 Hammond Road
St. PaulMinnesota
55110
USA

Crucial Supplier

Quadrant EPP Belgium N.V.
lndustriepark Noord
Robert Tavernierlaan 2Tielt
8700
Belgium

Manufacture

Page 2 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Smiths Healthcare Manufacturing
SA de CV
Avenida Calidad No.4Parque, Industrial Internacional
Tijuana
22425
MexicoManufacture

Smiths Healthcare Manufacturing
SA de CV
Carretera Miguel Alemán Km 21.7
Parque Industrial Monterrey
Apodaca
Nuevo León
66603
MexicoManufacture

Page 3 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant SubcontractorsRecognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Smiths Medical ASD Inc.
10 Bowman Dr.
Keene
New Hampshire
03431
USA

Manufacture

Smiths Medical ASD Inc.
1265 Grey Fox Road
St PaulMinnesota
55112
USA

Manufacture

Smiths Medical ASD Inc.
201 West Queen St.,Southington
Connecticut
06489
USA

Manufacture

Page 4 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary RoadHytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Smiths Medical ASD Inc.
6250 Shier Rings Road
Dublin
Ohio
43016
USA

Manufacture

Smiths Medical ASD Inc.
9124 Polk Lane, Suite 101
Olive Branch
Mississippi
38654
USADistribution

Smiths Medical Czech Republic a.s.
Olomoucká 306
753 01 Hranice
Czech Republic

Manufacture

Page 5 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Smiths Medical Gary
5700 W 23rd Ave
Gary
Indiana
46406
USA

Manufacture

Smiths Medical International Ltd
52 Grayshill Rd
Cumbernauld
Glasgow
G68 9HQ
United Kingdom

Manufacture

Smiths Medical International
NijmegenBijsterhuizen 22-08
6604 LD Wijchen
The Netherlands

Distribution

Page 6 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Smiths Medical Italia Srl
Via della Stazione, 2Latina Scalo
04100
Italy

Packaging

Sterigenics Belgium(Petit-Rechain) SA
Zoning Industriel de Petit-Rechain
Avenue Andre Ernst 21
B-4800 Verviers
Belgium

ETO Sterilization

Sterigenics UK Limited
Cotes Park Estate
Somercotes
Alfreton
DE55 4NJ
United Kingdom

ETO Sterilization

Page 7 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Sterigenics US, LLC
344 Bonnie Circle
CoronaCalifornia92880USAGamma Sterilization

Sterigenics, LLC
1700 College Blvd.
West Memphis
Arkansas
72301
USAGamma Sterilization

Sterilization Services ofTennessee, Inc2396 Florida StreetMemphis
Tennessee 38109
USAETO Sterilization

Page 8 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

UPG
Avenida La Cuspide #1
Parque Industrial TecnomexDel. Playas de Tijuana
Tijuana
Baja California
22700
MexicoManufacture

Velcro USA Inc.
95 Sundial Avenue
Manchester
New Hampshire
03103-7206
USA

Crucial Supplier

Page 9 of 9
Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 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 - Production Quality Assurance
Certificate History
Certificate No:

CE 661328

Date:

2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
CT21 6JL
United Kingdom

Date
Current

Reference
Number8693885
8603164

ActionFirst issue. Transferred from another Notified Body.
Certificate renewal.

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: + 44 345 080 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.