Manufacturer's By Device Catheter/overtube balloon inflator single-use-Catheter/overtube balloon inflator single-use, Catheter/overtube balloon inflator single-use Conformity Assessment Certificate Expired

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
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
ArcRoyal ucVirginia Road

Kells
Meath A82 R862

Ireland
RLD Quality LimitedCentenary House Peninsula Park
Rydon Lane
Exeter
Devon EX2 7XE

England United Kingdom
04/09/202216001
Atrion Medical Products Inc.1426 Curt Francis Road

Arab
35016

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

Cambridge
CB24 9BZ

England United Kingdom
11/08/202119954
B Braun Melsungen AGCarl-Braun-Straße 1

Melsungen
34212

Germany
B. Braun Medical LtdBrookdale Road Chapeltown

Sheffield
South Yorkshire S35 2PW

United Kingdom
04/04/202113080
Bard Peripheral Vascular Inc.1625 West 3rd Street

Tempe
Arizona 85281

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

Winnersh
RG41 5TS

England United Kingdom
04/22/202113711
Bard Peripheral Vascular Inc.1625 West 3rd Street

Tempe
Arizona 85281

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

Winnersh
RG41 5TS

England United Kingdom
04/22/202113711
Beijing Demax Medical Technology Co. Ltd.A13-7 Jingshengnansi Street Tongzhou District 101102 Beijing PEOPLE’S REPUBLIC OF CHINA

Tongzhou District/ Beijing
101102

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/06/202117284
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
Changzhou Intl. Trade & Enterprises Cooperative Co. Ltd. N0.20 Floor Huajing Building No.1 Hejing Garden Zhonglou District

Changzhou
Jiangsu 213000

China
Pennamed Limited30 Redcliff Road Melton Enterprise Park

Melton
East Yorkshire HU14 3RS

England United Kingdom
03/25/202212876
C.R. Bard Inc.8195 Industrial Blvd.

Covington
Georgia 30014

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

Winnersh
RG41 5TS

England United Kingdom
04/20/202113593
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
FORESIGHT TECHNOLOGY CO. LTD.16-12 No.18 Hongsheng Road

Jiangbei District
Chongqing 400020

China
Creo Medical UK LimitedBridgend Road Industrial Estate

Dingwall
Ross-Shire. Scotland IV15 9QF

Scotland United Kingdom
08/11/202116647
FUJIFILM Medwork GmbHMedworking 1

Höchstadt
91315

Germany
Fujifilm UK LimitedFujifilm House Whitbread Way

Bedford
MK42 0ZE

England United Kingdom
04/12/202217310
Jiangsu Changmei Medtech Co. Ltd.No.27 Xinke West Road Luoyang

Changzhou Jiangsu
213104

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
06/28/202225090
Jiangsu Vedkang Medical Science & Technology Co. Ltd.No.52 Guoxiang Road Wujin Economic Development Zone

Changzhou
Jiangsu 213149

China
Etheria Medical LtdThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA

United Kingdom
04/15/202219505
MedNet GmbHBorkstraße 10

Münster
48163

Germany
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202221919
Medtronic CryoCath LP9000 Trans-Canada Highway Pointe-Claire

Quebec
H9R 5Z8

Canada
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/24/202112845
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 Sofamor Danek Inc.1800 Pyramid Place

Memphis
TN TN 38132

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/09/202112579
Medtronic Sofamor Danek Inc.1800 Pyramid Place

Memphis
TN TN 38132

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/09/202112579
Medtronic Xomed Inc6743 Southport Drive North

Jacksonville
FL FL 32216

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/15/202112681
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
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
Micro-Tech (Nanjing) Co. LtdNO. 10 Gaoke Third Road Nanjing National Hi-tech Industrial Development Zone,

Nanjing
Jiangsu 210032

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202210570
Micro Therapeutics Inc. DBA ev3 Neurovascular9775 Toledo Way

Irvine
CA 92618

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/15/202112682
Optimum Medical Solutions LimitedTennant Hall Blenheim Grove

Leeds
West Yorkshire LS2 9ET

United Kingdom





02/09/20156401
Perouse MedicalRoute du Manoir

Ivry Le Temple
60173

France
Vygon (UK) LtdThe Pierre Simonet Building V Park Gateway North Latham Road

Swindon
Wiltshire SN25 4DL

United Kingdom
04/27/202113989
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
Shenzhen Antmed Co. Ltd.18 Jinhui Ave

Shenzhen
Pingshan New District 518122

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202222233
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
SIS Medical AGHungerbüelstrasse 12A

Frauenfeld
8500

Switzerland
VASCULAR PERSPECTIVES LIMITED35 WESTGATE

HUDDERSFIELD
WEST YORKSHIRE HD1 1PA

England United Kingdom
04/29/202114187
Spiggle & Theis Medizintechnik GmbHBurghof 14

Overath
51491

Germany
Minim Healthcare LimitedSt Mary's House 40 London Road

Newbury
Berkshire RG14 1LA

United Kingdom
04/21/202214492
Wilson-Cook Medical Inc.4900 Bethania Station Road

Winston-Salem
North Carolina 27105

United States
Cook (UK) Ltd3rd Floor 1 Ashley Road

Altrincham
Cheshire WA14 2DT

England United Kingdom
03/03/202112444
, G-Flex Europe SPRLRue de l'industrie 20

Nivelles
1400

Belgium
Abnovo LtdSuite 115 Wey House
15 Church Street
Weybridge
Surrey KT13 9EW

England United Kingdom
05/19/202220934