Manufacturer's By Device Cardiac/peripheral vascular guidewire single-use-Cardiac/peripheral vascular guidewire single-use, Cardiac/peripheral vascular guidewire single-use Conformity Assessment Certificate Expired

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Medical5050 Nathan Lane North

Plymouth
Minnesota 55442

United States
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom
01/15/202111588
Abbott Medical3200 Lakeside Drive

Santa Clara
California 95054

United States
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom
03/28/202112987
Abbott Medical3200 Lakeside Drive

Santa Clara
California 95054

United States
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom
03/28/202112987
Abbott Vascular3200 Lakeside Drive

Santa Clara
California 95054

United States
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom
02/16/202112177
Abiomed Inc.22 Cherry Hill Drive

Danvers
Massachusetts 01923

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
06/22/202225057
AGA Medical Corporation5050 Nathan Lane North

Plymouth
Minnesota 55442

United States
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom
02/18/202112223
Andratec GmbHSimmerner Str. 70

Koblenz
56075

Germany
ICARDIOLOGY. U.K. LTD Justa House 204-208 Holbrook Lane Coventry England CV6 4DD 204-208 Holbrook Lane

Coventry
CV64DD

England United Kingdom
05/01/202214288
Angiomed GmbH&Co. Medizintechnik KGWachhausstrasse 6

Karlsruhe
76227

Germany
Becton Dickinson U.K. Limited1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom
02/15/202112162
APT Medical Inc.Room 601 Building B Tongfang Information Port No.11 Langshan Road Nanshan District

Shenzhen
518057

China
Jump Start Consulting LimitedUnit 24 Cranfield Innovation Centre
University Way
Cranfield
Bedfordshire MK43 0BT

England United Kingdom
10/27/202118483
Argon Medical Devices Inc.1445 Flat Creek Road

Athens
Texas 75751

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
06/28/202225092
Arrow International LLC3015 Carrington Mill Blvd

Morrisville
North Carolina NC 27650

United States
TFX Group Ltd (T/A Teleflex Medical UK)Grosvenor House Horseshoe Crescent

Old Town Beaconsfield
Buckinghamshire HP9 1LJ

England United Kingdom
04/20/202113612
ASAHI Intecc Co LTD3-100 Akatsuki-cho

Seto-Shi
Aichi 489-0071

Japan
VASCULAR PERSPECTIVES LIMITED35 WESTGATE

HUDDERSFIELD
WEST YORKSHIRE HD1 1PA

England United Kingdom
04/20/202113585
Balt Extrusion SAS10 rue de la Croix Vigneron

Montmorency
95160

France
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
04/30/202114206
Bard Access Systems Inc.605 North 5600 West

Salt Lake City
Utah 84116

United States
Becton Dickinson U.K. Limited1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom
04/27/202114022
Bard Access Systems Inc.605 North 5600 West

Salt Lake City
Utah 84116

United States
Becton Dickinson U.K. Limited1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom
04/27/202114022
Baylis Medical Company Inc2645 Matheson Blvd

Ontario
East Mississauga L4W 5S4

Canada
Adveniunt Medical International Limited (trading as Quality First International)1 Cooks Road
Stratford
London
E15 2PW

England United Kingdom
02/03/20209558
Bioteque Corporation5F-6 No. 23 Sec.1 Chang-An E Rd

Taipei 104
104

Taiwan
It's Interventional Regulatory LimitedAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH

England United Kingdom
06/17/202115218
BIOTRONIK AGAckerstrasse 6

Bulach
8180

Switzerland
BIOTRONIK UK LIMITEDBIOTRONIK House Avonbury Business Park

Bicester
OX26 2UA

United Kingdom
03/25/202112897
Boston Scientific Corporation300 Boston Scientific Way

Marlborough
Massachusetts 01752

United States
Boston Scientific Limited100 New Bridge Street

London
EC4V 6JA

England United Kingdom
04/13/202113323
Boston Scientific Corporation300 Boston Scientific Way

Marlborough
Massachusetts 01752

United States
Boston Scientific Limited100 New Bridge Street

London
EC4V 6JA

England United Kingdom
04/13/202113323
Brivant Limited T/A Lake Region MedicalParkmore West Business Park

Galway
--- ---

Ireland
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
05/05/202114442
Brivant Limited T/A Lake Region MedicalParkmore West Business Park

Galway
--- ---

Ireland
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
05/05/202114442
Cardiac Pacemakers Inc. a subsidiary of Boston Scientific Corporation4100 Hamline Avenue North

St. Paul
Minnesota 55112

United States
Boston Scientific Limited100 New Bridge Street

London
EC4V 6JA

England United Kingdom
04/04/202113107
Cardiovascular Systems Inc.1225 Old Highway 8 NW

Saint Paul
Minnesota 55112

United States
ICON (LR) LimitedConcept House 6 Stoneycroft Rise
Chandlers Ford Eastleigh
Hampshire
SO53 3LD

England United Kingdom
07/23/202116219
Confluent Medical Technologies Inc.47533 Westinghouse Drive

Fremont
CA 94539

United States
QNET LtdLivingstone House 309 Harrow Road

Wembley
Middlesex HA9 6BD

England United Kingdom
11/01/202118711
Cordis Corporation14201 North West 60th Avenue

Miami Lakes
Florida 33014

United States
Cardinal Health UK 432 Ltd.Princes Exchange Princes Square

Leeds
West Yorkshire LS1 4HY

England United Kingdom
04/29/202114130
Cordis Corporation14201 North West 60th Avenue

Miami Lakes
Florida 33014

United States
Cardinal Health UK 432 Ltd.Princes Exchange Princes Square

Leeds
West Yorkshire LS1 4HY

England United Kingdom
08/18/202116879
Covidien llc15 Hampshire Street

Mansfield
MA 02048

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/26/202112973
Datascope Corp.15 Law Drive

Fairfield
07004

United States
Getinge Ltd.14-15 Burford Way Boldon Business Park
Boldon Colliery Tyne and Wear
Boldon
NE35 9PZ

England United Kingdom
04/15/202113415
Edwards Lifesciences LLCOne Edwards Way

Irvine
California 92614

United States
Edwards Lifesciences Ltd3 The Sector Newbury Business Park

Newbury
Berkshire RG14 2PZ

England United Kingdom
04/04/202113105
EPflex Feinwerktechnik GmbHIm Schwöllbogen 24

Dettingen an der Erms
72581

Germany
MEDAGENT INTERNATIONAL UK LIMITED2 St Andrews Place

Lewes
East Sussex BN7 1UP

England United Kingdom
04/15/202216556
EPflex Feinwerktechnik GmbHIm Schwöllbogen 24

Dettingen an der Erms
72581

Germany
MEDAGENT INTERNATIONAL UK LIMITED2 St Andrews Place

Lewes
East Sussex BN7 1UP

England United Kingdom
04/15/202216556
eV34600 Nathan Lane North

Plymouth MN
55442

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/26/202112964
Galt Medical Corp.2220 Merritt Drive

Garland
Texas 75041

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
05/12/202114612
Guangdong Baihe Medical Technology Co. LtdNo.89 Taoyuan East Road Nanhai Foshan Guangdong Province P.R. China

Fo Shan
528225

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/16/202116791
Heraeus Medical Components-Contract Medical International GmbHLauensteiner Strasse 37

Dresden
01277

Germany
MPS Medical-Product-Service UK LtdNorthgate House Northgate Street

Devizes
Wiltshire SN10 1JX

England United Kingdom
04/20/202113599
JOTEC GmbHLotzenäcker 23

Hechingen
72379

Germany
CryoLife Europa Ltd.Bramley House The Guildway Old Portsmouth Road
Old Portsmouth Road Guildford
Guildford
-- Please select - GU3 1LR

England United Kingdom
04/29/202114203
Kimal PLCArundel Road

Uxbridge
Middlesex UB8 2SA

England United Kingdom





04/30/20209899
Kimal PLCArundel Road

Uxbridge
Middlesex UB8 2SA

England United Kingdom





04/30/20209899
Lake Region Medical Ltd.Butlersland

New Ross
Co. Wexford Y34 K825

Ireland
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
05/05/202114440
Lake Region Medical340 Lake Hazeltine Drive

Chaska
Minnesota 55318

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
04/30/202114217
Maquet Cardiopulmonary GmbHKehler Str. 31

Rastatt
DE-76437

Germany
Getinge Ltd.14-15 Burford Way Boldon Business Park
Boldon Colliery Tyne and Wear
Boldon
NE35 9PZ

England United Kingdom
04/15/202113425
Medical Components Inc. (dba. Medcomp®)1499 Delp Drive

Harleysville
PA 19438

United States
MPS Medical-Product-Service UK LtdNorthgate House Northgate Street

Devizes
Wiltshire SN10 1JX

England United Kingdom
04/26/202113810
MEDOS INTERNATIONAL SARLCHEMIN-BLANC 38

LE LOCLE
2400

Switzerland
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
04/21/202113645
Medtronic CoreValve LLC1851 E. Deere Ave.

Santa Ana
CA 92705

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/26/202112980
Medtronic Inc710 Medtronic Parkway

Minneapolis
MN 55432

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
02/03/202211931
Medtronic Inc710 Medtronic Parkway

Minneapolis
MN 55432

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
02/03/202211931
Medtronic Inc710 Medtronic Parkway

Minneapolis
MN 55432

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
02/03/202211931
Merit Medical Systems Inc.1600 West Merit Parkway
1600 West Merit Parkway
South Jordan
Utah 84095

United States
Merit Medical UK LimitedUnit 27 Suttons Business Park Sutton Park Avenue Earley Reading Berkshire RG6 1AZ United Kingdom

Reading
Berkshire RG6 1AZ

England United Kingdom
03/05/202112487
Merit Medical Systems Inc.1600 West Merit Parkway
1600 West Merit Parkway
South Jordan
Utah 84095

United States
Merit Medical UK LimitedUnit 27 Suttons Business Park Sutton Park Avenue Earley Reading Berkshire RG6 1AZ United Kingdom

Reading
Berkshire RG6 1AZ

England United Kingdom
03/05/202112487
MicroVention Inc1311 Valencia Ave

Tustin CA
92780

United States
Adveniunt Medical International Limited (trading as Quality First International)1 Cooks Road
Stratford
London
E15 2PW

England United Kingdom
05/18/202114544
SentreHEART300 Saginaw Drive

Redwood City
California CA 94063

United States
AtriCure UK limited1 Princeton Mews 167-169 London Road

Kingston Upon Thames
Surrey KT2 6PT

England United Kingdom
02/17/202213108
Shanghai Kindly Medical Instruments Co Ltd.No 925 Jinyuan yi Road

Shanghai
201803

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202221805
Shunmei Medical Co. Ltd.R401 of Building B No.8 of 1st Jinglong Road Baolong Industrial Zone Longgang District Shenzhen

Guangdong Province
518116

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
09/21/202226052
Shunmei Medical Co. Ltd.R401 of Building B No.8 of 1st Jinglong Road Baolong Industrial Zone Longgang District Shenzhen

Guangdong Province
518116

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
09/21/202226052
Stryker Neurovascular a division of Stryker Corporation47900 Bayside Parkway

Fremont
California 94538

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/26/202112949
Stryker Neurovascular a division of Stryker Corporation47900 Bayside Parkway

Fremont
California 94538

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/26/202112949
St. Jude Medical Cardiac Rhythm Management Division15900 Valley View Court

Sylmar
California 91342

United States
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom
01/25/202111775
St. Jude Medical5050 Nathan Lane North

Plymouth
Minnesota 55442

United States
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom
02/13/202112122
Terumo Corporation44-1 2-chome Hatagaya Shibuya-ku

Tokyo
151-0072

Japan
Terumo UK LtdOtium House 2 Freemantle Road

Bagshot
Surrey GU19 5LL

England United Kingdom
04/29/202114114
Terumo Europe NVInterleuvenlaan 40

Leuven
3001

Belgium
Terumo UK LtdOtium House 2 Freemantle Road

Bagshot
Surrey GU19 5LL

England United Kingdom
04/15/202113412
Vascular Solutions LLCVascular Solutions LLC 6464 Sycamore Court North

Minneapolis
Minnesote 55369

United States
TFX Group Ltd (T/A Teleflex Medical UK)Grosvenor House Horseshoe Crescent

Old Town Beaconsfield
Buckinghamshire HP9 1LJ

England United Kingdom
04/27/202113961
Vascutek LtdNewmains Avenue Inchinnan Industrial Estate

Renfrewshire
Scotland PA4 9RR

United Kingdom





09/15/202010572
William Cook Europe ApSSandet 6

Bjæverskov
4632

Denmark
Cook (UK) Ltd3rd Floor 1 Ashley Road

Altrincham
Cheshire WA14 2DT

England United Kingdom
03/10/202112592