Manufacturer's By Device Buffered wash solution IVD automated/semi-automated system-Buffered wash solution IVD automated/semi-automated system

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott GmbHMax-Planck-Ring 2

Wiesbaden
65205

Germany
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202212352
Abbott Ireland Diagnostics DivisionFinisklin Business Park

Sligo
n/a

Ireland
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202212578
Abbott Laboratories Santa Clara4551 Great America Parkway

Santa Clara
CA 95054

United States
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202222929
Abbott LaboratoriesLake County Site 100 Abbott Park Road Abbott Park

Illinois
Illinois 60064

United States
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202219226
Agilent Technologies Singapore (International) Pte. LtdNo. 1 Yishun Avenue 7

Singapore
768923

Singapore
Agilent Technologies LDA UK Limited5500 Lakeside Cheadle Royal Business Park

Cheadle
Cheshire SK8 3GR

England United Kingdom
04/21/202113640
Agilent Technologies Singapore (International) Pte. LtdNo. 1 Yishun Avenue 7

Singapore
768923

Singapore
Agilent Technologies LDA UK Limited5500 Lakeside Cheadle Royal Business Park

Cheadle
Cheshire SK8 3GR

England United Kingdom
04/21/202113640
Bio-Rad Laboratories Inc. Clinical Immunology Division (CID)5500 East 2nd St.

Benicia
California 94510

United States
BIO-RAD LABORATORIES LIMITEDThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom
05/13/202221625
Bio-Rad3 boulevard Raymond Poincaré

Marnes-la-Coquette
92430

France
BIO-RAD LABORATORIES LIMITEDThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom
05/13/202221629
Biocare Medical LLC60 Berry Drive

Pacheco
California 94553

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

Cambridge
CB24 9BZ

England United Kingdom
02/01/202221674
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
BRAHMS GmbHNeuendorfstr. 25

Hennigsdorf
16761

Germany
Thermo Fisher Diagnostics Ltd.16 Shenley Pavillions Chalkdell Drive
Shenley Wood
Milton Keynes
MK5 6LB

England United Kingdom
07/11/202225259
BRAHMS GmbHNeuendorfstr. 25

Hennigsdorf
16761

Germany
Thermo Fisher Diagnostics Ltd.16 Shenley Pavillions Chalkdell Drive
Shenley Wood
Milton Keynes
MK5 6LB

England United Kingdom
07/11/202225259
Diagnostica Stago3 Allée Thérésa

Asnières-sur-Seine
92600

France
Diagnostica Stago UK2 Theale Lakes Business Park Moulden Way
Sulhamstead
Theale
RG7 4GB

England United Kingdom
06/14/202220960
DiaMed GmbHPro Rond 23

Cressier FR
1785

Switzerland
BIO-RAD LABORATORIES LIMITEDThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom
05/13/202221630
DiaSorin S.p.A.DiaSorin S.p.A.
Via Crescentino SALUGGIA
VC
Piemonte 13040

Italy
DiaSorin S.p.A. UK BranchCentral Road

Dartford
DA1 5LR

United Kingdom
04/27/202113991
Diesse Diagnostica Senese SpaDiesse Diagnostica Senese Spa Sede Legale e Amm.ne
Via A. Solari 19 MONTERIGGIONI
MI
20144

Italy
IVDeology UKRP Ltd22-23 The Joiners Shop Historic Dockyard
Chatham
Rochester
Kent ME4 4TZ

England United Kingdom
07/14/202115944
EUROIMMUN Medizinische Labordiagnostika AGSeekamp 31

Lubeck
23560

Germany
Euroimmun UK LimitedAshville House 131-139 The Broadway

Wimbledon
London SW19 1QJ

England United Kingdom
05/05/202114448
EUROIMMUN Medizinische Labordiagnostika AGSeekamp 31

Lubeck
23560

Germany
Euroimmun UK LimitedAshville House 131-139 The Broadway

Wimbledon
London SW19 1QJ

England United Kingdom
05/05/202114448
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
Fujirebio Inc.2-1-1 Nishishinjuku

Tokyo
Shinjuku-ku 163-0410

Japan
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
12/13/202120498
Helena Biosciences EuropeQueensway South Team Valley Trading Estate

Gateshead
Tyne And Wear NE11 0SD

United Kingdom





03/30/20157193
HORIBA ABX SASParc Euromédecine - Rue du Caducée BP 7290

34184 Montpellier
34184

France
HORIBA UK LimitedKYOTO CLOSE MOULTON PARK

NORTHAMPTON
Northants NN3 6FL

United Kingdom
04/15/202220418
INOVA Diagnostics9900 Old Grove Road

San Diego
CA 92131

United States
Werfen Ltd712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE

England United Kingdom
04/13/202221374
Leica Biosystems Newcastle LtdBalliol Business Park West Benton Lane

Newcastle upon Tyne
NE12 8EW

United Kingdom





11/29/20199362
Leica Biosystems Newcastle LtdBalliol Business Park West Benton Lane

Newcastle upon Tyne
NE12 8EW

United Kingdom





11/29/20199362
MEDCAPTAIN Medical Technology Co. Ltd.12th Floor Baiwang Research Building No.5158 Shahe West Road Xili Nanshan

Shenzhen Guangdong
518055

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
02/22/202112290
NeoMedica dooBulevar Svetog Cara Konstantina 82-86

Nis
18103

Serbia
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
11/26/202011006
NeuMoDx Molecular1250 Eisenhower Pl Ann Arbor

Washtenaw
MI 48108-3281

United States
QIAGEN Manchester Ltd.QIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH

England United Kingdom
03/31/202213041
NeuMoDx Molecular1250 Eisenhower Pl Ann Arbor

Washtenaw
MI 48108-3281

United States
QIAGEN Manchester Ltd.QIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH

England United Kingdom
03/31/202213041
Ortho-Clinical Diagnostics Inc.100 Indigo Creek Drive

Rochester
New York 14626

United States
Ortho-Clinical DiagnosticsFelindre Meadows Pencoed

Bridgend
CF35 5PZ

Wales United Kingdom
12/04/20157248
Oxoid LimitedWade Road

Basingstoke
RG24 8PW

England United Kingdom





04/17/20157191
Radiometer Medical ApSAakandevej 21 Broenshoej

Copenhagen
2700

Denmark
Radiometer LimitedManor Court/Manor Royal

Crawley
RH10 9FY

England United Kingdom
01/06/202221058
Radiometer Medical ApSAakandevej 21 Broenshoej

Copenhagen
2700

Denmark
Radiometer LimitedManor Court/Manor Royal

Crawley
RH10 9FY

England United Kingdom
01/06/202221058
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
RR Mechatronics Manufacturing B.V.Corantijn 13

Zwaag
Noord Holland 1689 AN

Netherlands
Qserve Group UK Ltd. 49 Greek Street

London
W1D 4EG

England United Kingdom
08/10/202225488
Shenzhen Dymind Biotechnology Co.Ltd.10th Floor Building B High-tech Park GuangqiaoRoad Tianliao Community Yutang Street Guangming District Shenzhen 518107 P.R. China

Shenzhen
518107

China
PureUKCA Ltd59 St. Martin's Lane

London
Middlesex WC2N 4JS

England United Kingdom
04/14/202219994
Shenzhen Lifotronic Technology Co. Ltd.Unit A 4th Floor Building 15 Yijing Estate No.1008 Songbai Road Nanshan District

Shenzhen
518055

China
PureUKCA Ltd59 St. Martin's Lane

London
Middlesex WC2N 4JS

England United Kingdom
04/14/202220799
Siemens Healthcare Diagnostics Inc511 Benedict Avenue

Tarrytown
NY 10591

United States
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
04/01/201534
Siemens Healthcare Diagnostics Products GmbHEmil-Von-Behring-Str. 76

Marburg
35041

Germany
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
11/09/202119197
SYSMEX CORPORATION1-5-1 Wakinohama-Kaigandori Chuo-Ku

Kobe
Hyogo 651-0073

Japan
OXFORD GENE TECHNOLOGY (OPERATIONS) LTDBegbroke Science Park Begbroke Hill
Woodstock Road
Begbroke
Oxfordshire OX5 1PF

England United Kingdom
12/21/202120783
SYSMEX PARTEC GMBHArndtstrae 11 a-b

Görlitz
Saxony 02826

Germany
OXFORD GENE TECHNOLOGY (OPERATIONS) LTDBegbroke Science Park Begbroke Hill
Woodstock Road
Begbroke
Oxfordshire OX5 1PF

England United Kingdom
11/10/202120030
SYSMEX PARTEC GMBHArndtstrae 11 a-b

Görlitz
Saxony 02826

Germany
OXFORD GENE TECHNOLOGY (OPERATIONS) LTDBegbroke Science Park Begbroke Hill
Woodstock Road
Begbroke
Oxfordshire OX5 1PF

England United Kingdom
11/10/202120030
Tcoag Ireland LtdTcoag Ireland Ltd IDA Business Park
Southern Cross
Bray
Co. Wicklow A98X383

Ireland
Diagnostica Stago UK2 Theale Lakes Business Park Moulden Way
Sulhamstead
Theale
RG7 4GB

England United Kingdom
12/22/202121421
The Binding Site Group Limited8 Calthorpe Road Edgbaston

Birmingham
West Midlands B15 1QT

United Kingdom





04/24/20157217
The Binding Site Group Limited8 Calthorpe Road Edgbaston

Birmingham
West Midlands B15 1QT

United Kingdom





04/24/20157217
Tosoh CorporationShiba-koen First Bldg. 3-8-2 Shiba Minato-ku

Tokyo
105-8623

Japan
Tosoh Bioscience LimitedLytchett House Wareham Road
13 Freeland Park
Poole
Dorset BH16 6FA

England United Kingdom
04/27/202215586
Tosoh EuropeTransportstraat 4
=
Tessenderlo
3980

Belgium
Tosoh Bioscience LimitedLytchett House Wareham Road
13 Freeland Park
Poole
Dorset BH16 6FA

England United Kingdom
04/27/202212846
Ventana Medical Systems Inc.1910 E Innovation Park Drive

Tucson
AZ 85755

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
03/26/202112951
Ventana Medical Systems Inc.1910 E Innovation Park Drive

Tucson
AZ 85755

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
03/26/202112951
Wallac OyMustionkatu 6

Turku
20750

Finland
Perkinelmer LtdChalfont Road Seer Green

Beaconsfield
Bucks HP9 2FX

United Kingdom
04/04/202220247