Manufacturer's By Device Electrocardiographic lead set reusable-Electrocardiographic lead set reusable, Electrocardiographic lead set reusable Conformity Assessment Certificate Expired

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Amedtec Medizintechnik Aue GmbHSchneeberger Strasse 5

AUE
08280

Germany
Love Medical LtdUnit 1 Willan Enterprise Centre Fourth Avenue Trafford Park
MANCHESTER
MANCHESTER
Lancashire M17 1DB

England United Kingdom
09/16/202117613
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
BIOTRONIK SE & Co. KGWoermannkehre 1

Berlin
12161

Germany
BIOTRONIK UK LIMITEDBIOTRONIK House Avonbury Business Park

Bicester
OX26 2UA

United Kingdom
03/08/202112556
BIOTRONIK SE & Co. KGWoermannkehre 1

Berlin
12161

Germany
BIOTRONIK UK LIMITEDBIOTRONIK House Avonbury Business Park

Bicester
OX26 2UA

United Kingdom
03/08/202112556
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
Braebon Medical Corporation1-100 Schneider Road Kanata

Ottawa
Ontario K2K1Y2

Canada
UKCApartner4U Limited7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom
02/09/202222825
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
ConMed Corporation525 French Road

Utica
13502

United States
ConMed UK Ltd73/76 Shrivenham Hundred Business Park

Swindon
Wiltshire SN6 8TY

England United Kingdom
05/18/202114753
Defibtech LLCBoston Post Road 741

Guilford
06437

United States
NIHONKOHDEN UK LTDUnit 3 Heyworth Business Park Old Portsmouth Road Peasmarsh
GUILDFORD
GUILDFORD
Surrey GU3 1AF

England United Kingdom
09/03/202117259
dms-service llc11845 West Olympic Blvd Ste 880W

Los Angeles
California 90064

United States
NB Insight Ltd39 Lambourn Avenue Stone Cross
Pevensey
Pevensey
East Sussex BN24 5PQ

England United Kingdom
06/21/202115357
Draeger Medical Systems Inc6 Tech Dr MA 01810

Andover
MA 01810

United States
Draeger Medical UK Ltd The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
03/12/202212610
Draeger Medical Systems Inc3135 quarry Road

telford
18969

United States
Draeger Medical UK Ltd The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
04/07/202113156
Dragerwerk AG & Co. KGaAMoislinger Allee 53-55 Lübeck Germany

Lübeck
23542

Germany
Draeger Medical UK Ltd The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
04/08/202213157
Dragerwerk AG & Co. KGaAMoislinger Allee 53-55 Lübeck Germany

Lübeck
23542

Germany
Draeger Medical UK Ltd The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
04/08/202213157
Dragerwerk AG&Co. KGaAMoislinger Allee 53-55

Lubeck
23558

Germany
Draeger Medical UK Ltd The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
04/06/202212607
Dragerwerk AG&Co. KGaAMoislinger Allee 53-55

Lubeck
23558

Germany
Draeger Medical UK Ltd The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
04/06/202212607
Edan Instruments Inc. #15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District Shenzhen P.R.China.

Shenzhen
518122

China
EDAN Medical (UK) Ltd8 Charter Gate Clayfield Close
Moulton Park
Northampton
Northants NN3 6QF

England United Kingdom
08/17/202116848
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
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
Fujifilm Sonosite Inc21919 30th Drive SE

Bothell
Washington 98021

United States
Fujifilm UK LimitedFujifilm House Whitbread Way

Bedford
MK42 0ZE

England United Kingdom
04/12/202218111
FUJIFILM Sonosite Inc21919 30th Drive SE

Bothell
Washington 98021

United States
Fujifilm UK LimitedFujifilm House Whitbread Way

Bedford
MK42 0ZE

England United Kingdom
04/12/202218196
FUJIFLM Sonosite Inc21919 30th Drive SE

Bothell
Washington 98021

United States
Fujifilm UK LimitedFujifilm House Whitbread Way

Bedford
MK42 0ZE

England United Kingdom
04/12/202218195
Fukuda Denshi Co. Ltd.3-39-4 Hongo Bunkyo-ku

Tokyo
113-8483

Japan
FUKUDA DENSHI UK LTDUnit 6 Chambers Way
Thorncliffe Park Estate Chapeltown
Sheffield
South Yorkshire S35 2PH

England United Kingdom
03/11/202218807
FUKUDA DENSHI UK LTDUnit 6 Chambers Way
Thorncliffe Park Estate Chapeltown
Sheffield
South Yorkshire S35 2PH

England United Kingdom





03/11/202212598
GE Medical Systems Information Technologies Inc.9900 Innovation Drive

Wauwatosa
53226

United States
GE Medical Systems LimitedPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP

England United Kingdom
04/15/202217029
Huizhou Carefit Medical Electronic Co. Ltd.4 Floor-A Jianmin Pharmaceutical Building Taoqian New Village
Sandong Town Huicheng District
Huizhou City Guangdong
516007

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/21/202113649
Huizhou Carefit Medical Electronic Co. Ltd.4 Floor-A Jianmin Pharmaceutical Building Taoqian New Village
Sandong Town Huicheng District
Huizhou City Guangdong
516007

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/21/202113649
Invivo a division of Philips Medical Systems12151 Research Parkway

Orlando
Florida 32826

United States
Philips Electronics UK LtdAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW

England United Kingdom
09/16/202117559
Invivo a division of Philips Medical Systems12151 Research Parkway

Orlando
Florida 32826

United States
Philips Electronics UK LtdAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW

England United Kingdom
09/16/202117559
MECTA Corporation19799 SW 95th Avenue Tualatin

Oregon
Oregon 97062

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

England United Kingdom
10/19/202118407
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
METKO (Medical Engineering Trade Company)IVEDIK O.B.S AGAC ISLERI SANAYI SITESI 1354.CADDE
1358.SOKAK No. 9 0637 YENIMAHALLE
ANKARA
06378

Turkey
European Device Solutions Ltd15 COANWOOD DRIVE Whitley Bay

WHITLEY BAY
TYNE AND WEAR NE25 9GB

England United Kingdom
04/13/202223610
Microport CRM S.r.lVia Crescentino s.n.
Via Crescentino s.n.
Saluggia
VC 13040

Italy
MicroPort CRM LtdWillow House Sealand Road
Park West
Chester
Cheshire CH1 4RW

England United Kingdom
03/23/202112824
Miracor Medical SARue de Bruxelles 174 E40 Business Park

Awans
B-4340

Belgium
Miracor Medical UK LimitedWater Eaton Ind. Estate 39 Barton Road

Bletchley Milton Keynes
MK2 3HW

England United Kingdom
05/24/202214973
Neoventa Medical ABNorra Ågatan 32

Mölndal
43135

Sweden
Neoventa Medical Ltd 34 Anyards Road

Cobham
Surrey KT 11 2LA

England United Kingdom
11/05/202119846
Nissha Medical Technologies SAS23-25 Boulevard de la Paix

Cergy
95800

France
Nissha Medical Technologies LtdTorbay Business Park Woodview Road

Paignton
Devon TQ4 7HP

United Kingdom
11/09/202119317
Norav Medical Ltd4 Hamada Street / PO Box 81 Yokneam Industrial Park

Hadera
2069202

Israel
Physiological Measurements LimitedThe Old Malt House Willow Street

Oswestry
Shropshire SY11 1AJ

England United Kingdom
04/04/202224001
Nox MedicalKatrinartuni 2

Reykjavik
IS-105

Iceland
Qserve Group UK Ltd. 49 Greek Street

London
W1D 4EG

England United Kingdom
04/15/202217783
Orantech Inc.Zone#A 4F 1st Bld 7th Industrial Zone Yulv Community GongMing Guangming New District Shenzhen China.518106

Shenzhen
518106

China
Patient Guard LimitedLancaster House Amy Johnson Way

Blackpool
Lancashire FY42RP

United Kingdom
05/17/202214705
Philips Medical Systems (Andover)3000 Minuteman Road

Andover
MA 01810-1099

United States
Philips Electronics UK LtdAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW

England United Kingdom
11/12/202119066
Philips Medical Systems (Andover)3000 Minuteman Road

Andover
MA 01810-1099

United States
Philips Electronics UK LtdAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW

England United Kingdom
11/12/202119066
Philips Medical Systems22100 Bothell Everett Highway

Bothell
WA 98021-8431

United States
Philips Electronics UK LtdAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW

England United Kingdom
09/16/202117560
Philips Medizin Systeme Böblingen GmbHHewlett-Packard-Strasse 2

Böblingen
71034

Germany
Philips Electronics UK LtdAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW

England United Kingdom
09/03/202116800
Physio-Control Inc.11811 Willow Road

NE Redmond
Washington 98052

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/08/202112464
Remote Diagnostic Technologies Ltd.Ascent 1 Farnborough Aerospace Centre
Aerospace Boulevard
Farnborough
Hampshire GU14 6XW

England United Kingdom





11/30/2018842
Shanghai Kohden Medical Electronic Instrument Corp.Huancheng Bei Road 567

Shanghai
Fengxian District 201401

China
NIHONKOHDEN UK LTDUnit 3 Heyworth Business Park Old Portsmouth Road Peasmarsh
GUILDFORD
GUILDFORD
Surrey GU3 1AF

England United Kingdom
09/02/202217211
Shenzhen Caremed Medical Technology Co. Ltd.East Side 3/F C Building Kelunte Low-Carbon Industrial Park Gaofeng Community Dalang Office Longhua District Shenzhen

Guangdong Province
518109

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
06/30/202115643
Shenzhen Changke Connect Electronics Co. Ltd.A2-4th floor of factory building No.87 of Hengping Road Baoan Community Yuanshan Street
Longgang District
Shenzhen
518115

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
08/17/202116833
Shenzhen Changke Connect Electronics Co. Ltd.A2-4th floor of factory building No.87 of Hengping Road
Baoan Community Yuanshan Street Longgang District
Shenzhen Guangdong
518115

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
06/08/202224798
Shenzhen Med-link Electronics Tech Co. LTD.4th and 5th Floor Building Two Hualian Industrial Zone Xinshi Community Dalang Street Longhua District

Shenzhen Guangdong
518109

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202213239
Shenzhen SINO-K Medical Technology Co. Ltd.Room 401 Bldg 2 Veteran Ind. City Gongle Community Xixiang S treet Baoan District

Shenzhen
518102

China
PROLINX GLOBAL LTD27 Old Gloucester Street

London
WC1N 3AX

England United Kingdom
09/20/202226033
Shenzhen Taijia Electronics Co. Ltd5F Buding20 5 zone Baiwangxin Industrial Park Songbai Road

Shenzhen
Nanshan 518055

China
Neoventa Medical Ltd 34 Anyards Road

Cobham
Surrey KT 11 2LA

England United Kingdom
12/22/202121437
Spacelabs Healthcare Inc.35301 SE Center St

Snoqualmie
WA 98065

United States
Spacelabs Healthcare LtdUnit B Foxholes Centre Harforde Court
John Tate Road
Hertford
SG13 7DT

United Kingdom
06/08/202115095
Spacelabs Healthcare LtdUnit B Foxholes Centre Harforde Court
John Tate Road
Hertford
SG13 7DT

United Kingdom





05/01/20209913
Spacelabs Healthcare LtdUnit B Foxholes Centre Harforde Court
John Tate Road
Hertford
SG13 7DT

United Kingdom





05/01/20209913
Unimed Medical Supplies IncBld#8 Nangang 3rd Industrial Park Tangtou Shiyan 518108 Shenzhen PEOPLE’S REPUBLIC OF CHINA

Shenzhen
Guangdong Province 518108

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/02/202117255
Unimed Medical Supplies IncBld#8 Nangang 3rd Industrial Park Tangtou Shiyan 518108 Shenzhen PEOPLE’S REPUBLIC OF CHINA

Shenzhen
Guangdong Province 518108

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/02/202117255
Vyaire Medical OyKuortaneenkatu 2

Helsinki
FI-00510

Finland
Vyaire Medical Products LimitedChineham Gate Chineham Business Park Crockford Lane

Basingstoke
RG24 8NA

England United Kingdom
09/16/202117585
Welch Allyn Inc.4341 State Street Road

Skaneateles Falls
NY 13153

United States
Baxter Healthcare LtdCaxton Way

Thetford
Norfolk IP24 3SQ

England United Kingdom
09/02/202225772
Welch Allyn Inc.4341 State Street Road

Skaneateles Falls
NY 13153

United States
Baxter Healthcare LtdCaxton Way

Thetford
Norfolk IP24 3SQ

England United Kingdom
09/02/202225772