EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4No.

CE 661325

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKent
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 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):

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 661325

Certificate Scope:
The design, development and manufacture of sterile:
Breathing Systems, Drainage Devices, Feeding Devices, Filtration Devices for Breathing
Circuits, Infusion Disposables, Intubation Systems, Obstetrics and Gynaecology Sampling
Devices, Oxygen and Humidity Management Devices, Pressure Monitoring Accessories,
Resuscitation Devices, Suction Catheters, Tracheostomy Tubes, Vascular Access Devices
The design, development and manufacture of non-sterile:
Breathing Systems, Intubation Systems, Resuscitation Devices, Gynecologic Pessaries,
Tracheostomy Tubes, Oxygen and Humidity Management 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 - 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 661325

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 CorporationNo. 87, Li-Gong 2nd Road
Wu-JiaYILAN 268Taiwan

Manufacture

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

Manufacture

Page 1 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 - 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 661325

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 Park
Songjiang, 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 - 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 661325

Date:2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary Road
HytheKentCT21 6JL
United Kingdom

Subcontractor:

Service(s) supplied

Smiths Healthcare Manufacturing
SA de CV
Avenida Calidad No.4
Parque, 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 - 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 661325

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
USAManufacture

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

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 - 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 661325

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.
6250 Shier Rings Road
Dublin
Ohio
43016
USA

Manufacture

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

Distribution

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 - 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 661325

Date:2017-06-28

Issued To:

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

Subcontractor:

Service(s) suppliedSmiths Medical Gary
5700 W 23rd Ave
GaryIndiana
46406
USAManufacture

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

Manufacture

Smiths Medical International
NijmegenBijsterhuizen 22-086604 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 - 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 661325

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 - 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 661325

Date:2017-06-28

Issued To:

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

Subcontractor:

Service(s) supplied

Sterigenics US, LLC
344 Bonnie Circle
CoronaCalifornia
92880
USA

Gamma Sterilization

Sterigenics, LLC
1700 College Blvd.
West Memphis
Arkansas
72301
USA

Gamma Sterilization

Sterilization Services ofTennessee, Inc
2396 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 - 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 661325

Date:2017-06-28

Issued To:

Smiths Medical International Ltd.
Boundary RoadHytheKent
CT21 6JL
United KingdomSubcontractor:

Service(s) supplied

STERIS ISOMEDIX Services, Inc7685 Saint Andrews Avenue
San Diego
California 92154
USAETO Sterilization

UPGAvenida 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 - Full Quality Assurance System
Certificate History
Certificate No:

CE 661325

Date:2017-06-28

Issued To:

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

Date
Current

Reference
Number8603100
8603169

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.