Manufacturer's By Device Glycated haemoglobin (HbA1c) IVD reagent-Glycated haemoglobin (HbA1c) IVD reagent

Displaying 1 to 27 of 27

Page(s) 1
Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
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
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
Assure Tech. (Hangzhou) Co. Ltd.Building 4 No 1418-50 Moganshan Road Gongshu District

Zheijiang
Hangzhou 310011

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
05/13/202224626
Atlas Medical GmbHLudwig-Erhard-Ring 3 15827 Blankenfelde-Mahlow

Berlin
15827

Germany
Atlas MedicalWilliam James House Cowley Road

Cambridge
CB4 0WX

United Kingdom
04/21/202113630
Axis-Shield Diagnostics LtdLuna place The technology park

Dundee
DD2 1XA

Scotland United Kingdom





02/11/202112093
Beckman Coulter Inc.250 South Kraemer Boulevard

Brea
California -

United States
Beckman Coulter UK LtdOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU

United Kingdom
04/19/202214139
Bio-Rad Laboratories Inc. Clinical Systems Division (CSD)4000 Alfred Nobel Drive

Hercules
94547

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
05/13/202221626
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Boditech Med Inc.43 Geodudanji 1-gil Dongnae-myeon Chuncheon-si Gang-won-do 24398 Republic of Korea

Chuncheon-si
24398

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
05/24/202328282
Changsha Sinocare Inc.No. 265 Guyuan Road Hi-tech Zone Changsha

Hunan Province
410205

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
05/29/202114945
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
EKF-diagnostic GmbHEbendorfer Chaussee 3

Barleben
D-39179

Germany
EKF Diagnostics Holdings plcAvon House 19 Stanwell Road
Penarth
Cardiff
CF64 2EZ

Wales United Kingdom
10/03/202220794
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
Helena Biosciences EuropeQueensway South Team Valley Trading Estate

Gateshead
Tyne And Wear NE11 0SD

United Kingdom





03/30/20157193
HORIBA Instruments IncorporatedPointe/Pointe Scientific 5449 Research Drive

Canton
Michigan MI 48188

United States
HORIBA UK LimitedKYOTO CLOSE MOULTON PARK

NORTHAMPTON
Northants NN3 6FL

United Kingdom
01/24/202327658
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
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
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
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
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
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
04/14/202220804
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
04/14/202221169
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
04/14/202221170
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
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
Trinity Biotech (Primus Corporation dba Trinity Biotech)4231 E. 75th Terrace

Kansas City
Missouri 64132

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

England United Kingdom
01/18/202221309