Manufacturer's By Device Glycated haemoglobin (HbA1c) IVD control-Glycated haemoglobin (HbA1c) IVD control, Glycated haemoglobin (HbA1c) IVD control Conformity Assessment Certificate Expired

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Aalto Scientific Ltd.230 Technology Pkwy

Eatonton GA
31024

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
09/23/202117759
Abbott Diagnostics Technologies ASKjelsasveien 161 P.O. Box 6863 Rodelokka

Oslo
NO-0504

Norway
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
07/29/202116309
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 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
Aidian OyKoivu-Mankkaan tie 6 B

Espoo
02200

Finland
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
12/22/202121428
ARKRAY Factory Inc.1480 Koji Konan-cho
Koka-shi
Shiga
520-3306

Japan
Arkray LtdBeacon House Ibstone Road
Stokenchurch Business Park
High Wycombe
Buckinghamshire HP14 3FE

England United Kingdom
08/06/202116431
ARKRAY Factory Inc.1480 Koji Konan-cho
Koka-shi
Shiga
520-3306

Japan
Arkray LtdBeacon House Ibstone Road
Stokenchurch Business Park
High Wycombe
Buckinghamshire HP14 3FE

England United Kingdom
08/06/202116431
Axis-Shield Diagnostics LtdLuna place The technology park

Dundee
DD2 1XA

Scotland United Kingdom





02/11/202112093
Bio-Rad Laboratories Inc.Clinical Diagnostics Group 9500 Jeronimo Road

Irvine
California 92618-2017

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
05/13/202221670
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Diazyme Laboratories Inc.12889 Gregg Court

Poway CA
92064

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
06/14/202224869
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
Getein Biotech Inc.No.9 Bofu Road Luhe District

Nanjing
211505

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
02/09/202222849
Glenbio Ltd.10 Kilbegs Road

Antrim
Co. Antrim BT41 4NN

Northern Ireland United Kingdom





08/28/20157208
Goldsite Diagnostics Inc.No. 103C 503C & 504D Technology Building & No. 3A & 4A Technology Building Annex Zhaoshang Sub-District

Nanshan District
Shenzhen 518067

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/25/202225708
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
i-SENS Inc.43 Banpo-daero 28-gil Seocho-gu

Seoul
06646

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
07/27/202116302
LGC Clinical Diagnostics Inc.221 US Route 1

Cumberland Foreside ME
04110

United States
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
01/24/202222089
LumiraDx UK Ltd.Unit 1 Block 5 Dumyat Business Park
Bond Street
Alloa
FK102PB

United Kingdom





05/06/20209941
Microgenics Corporation46500 Kato Road

Fremont
California CA 94538

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

England United Kingdom
07/14/202225266
Nova Biomedical Corporation200 Prospect Street

Waltham
MA 02454-9141

United States
Nova Biomedical CorporationInnovation House Aston Lane South
Runcorn
Runcorn
Cheshire WA7 3FY

England United Kingdom
05/18/202217568
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
OSANG Healthcare Co. Ltd.132 Anyangcheondong-ro Dongan-gu

Anyang-si
Gyeonggi-do 14040

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
10/04/202117967
Polymer Technology Systems Inc.4600 Anson Boulevard

Whitestown IN
46075

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
03/07/202223232
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
Primus Corporation dba Trinity Biotech Kansas CityPrimus Corporation dba Trinity Biotech Kansas City 6080 Jericho Turnpike
Suite 208
NY
Commack 11725

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

England United Kingdom
01/18/202221309
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
05/11/202114605
SebiaParc Technologique Leonard de Vinci CO 8010 Lisses

Evry
91108

France
Sebia (UK) LTDRiver Court Meadows Business Park Station Approach Blackwater
Camberley
Camberley
Surrey GU17 9AB

England United Kingdom
12/17/202120773
SEKISUI MEDICAL CO. LTD.1-3 Nihonbashi 2-chome Chuo-ku

Tokyo
103-0027

Japan
Sekisui Diagnostics (UK) LtdSekisui Diagnostics (UK) Ltd Liphook Way
Allington
Maidstone
Kent ME19 0LQ

England United Kingdom
12/22/202121453
SENTINEL CH. S.p.A.Via Robert Koch 2
Milano
MI
Lombardia 20152

Italy
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
08/10/202116678
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
04/14/202220801
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 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
Streck Laboratories Inc.7002 S. 109th Street

La Vista
Nebraska 68128

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

Cambridge
CB24 9BZ

England United Kingdom
01/20/202221376
Thermo Fisher Scientific OyRatastie 2

Vantaa
Uusimaa 01620

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

England United Kingdom
07/12/202225260
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
Weqas Quality LaboratoryUnit 6 Parc Ty Glas Llanishen

Cardiff
South Glamorgan CF14 5DU

United Kingdom





07/31/20136776
Wuxi BioHermes Bio & Medical Technology Co. Ltd.No. 136 Mashan Meiliang Road Binhu

Wuxi
Jiangsu 214092

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
09/12/202217961
Wuxi BioHermes Bio & Medical Technology Co. Ltd.No. 136 Mashan Meiliang Road Binhu

Wuxi
Jiangsu 214092

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
09/12/202217961