Manufacturer's By Device SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)-SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Scarborough Inc.10 Southgate Rd

Scarborough
Maine 04074

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

England United Kingdom
07/08/202115830
ACON Biotech (Hangzhou) Co LtNo 210 Zhenzhong Road West Lake District

Hangzhou
310030

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
02/10/202111766
Acon Laboratories Inc.5850 Oberlin Drive #340

San Diego CA
92121

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
04/07/202113082
Acro Biotech Inc.9500 7th Street Unit M

Rancho Cucamonga
CA 91730

United States
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
04/26/202113601
Almac Diagnostic Services Ltd19 Seagoe Industrial Estate

Craigavon
BT63 5QD

Northern Ireland United Kingdom





12/31/999911230
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
AMS UK (NI) Limited42 Ballymena Business Centre

Ballymena
Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157209
Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞEgitim Mah. Kasap Ismail Sk.
No: 10/23
Istanbul
Kadikoy 34722

Turkey
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
04/28/202114050
Atila BioSystems Inc.740 Sierra Vista Ave

Mountain View
California 94043

United States
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
03/19/202112751
bioMérieux S.AbioMérieux S.A

Marcy L'Etoile (69280)
69280

France
bioMérieux UK LtdGrafton House Grafton Way Unit H

Basingstoke
Hampshire RG22 - 6HY

England United Kingdom
03/30/202113038
BIONEER Corporation8-11 Munpyeongseo-ro

Daedeok-gu
Daejeon 34202

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

Oxford
OX1 2EP

England United Kingdom
04/26/202113753
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
BioTeke Corporation (Wuxi) Co. Ltd4th Floor D5 & 2nd Floor D3 & 1st and 2nd Floor D16 No. 1719 Huishan Avenue Wuxi

Jiangsu Province
214174

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
04/21/202112460
Birmingham Biotech LTD29-31 Castle Street

High Wycombe
HP13 6RU

England United Kingdom





12/31/999911084
Chronomics Limited1 St. James Court

Norwich
NR3 1RU

England United Kingdom





12/31/999912347
CITEST DIAGNOSTICS INC170-422 Richards Street Vancouver BC
V6B 2Z4 Canada
Vancouver
V6B 2Z4

Canada
UK RepMed Ltd.Wey Court West Union Road
Farnham Surrey
Farnham
GU9 7PT

England United Kingdom
08/11/202116644
Delta Diagnostics (UK) Ltd T/A Elucigene DiagnosticsCitylabs Nelson Street

Manchester
M13 9NQ

United Kingdom





07/24/20155848
Department of Health and Social CareJuno Drive Axiom Building

Leamington Spa
Warwickshire CV31 3HH

England United Kingdom





12/31/999910307
Diagnostics for the Real World LtdDiagnostics for the Real World Ltd 845 Embedded Way suite 150

San Jose
CA 95138

United States
Diagnostics For The Real World (Europe) LtdSuite 12 Science Village
Chesterford Research Park
Little Chesterford
Essex CB10 1XL

United Kingdom
02/27/202112398
Diasia Biomedical Technology Co. Ltd.3th B 4th Floor Building No.4 Chuangfu Industrial Park Xixiang Tiegang Reservoir Road
Baoan District
Shenzhen
518012

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
03/22/202112549
Edinburgh Genetics Limited64a Cumberland Street

Edinburgh
EH3 6RE

United Kingdom





12/31/99999761
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
FLUXERGY INC30 FAIRBANKS SUITE 110

IRVINE
CALIFORNIA 92618

United States
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
07/01/202115631
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
Genedrive Diagnostics48 Grafton Street

Manchester
M139XX

United Kingdom





12/31/99999327
GeneSign Biotech (Xiamen) Co. Ltd.Unit03 8th Floor Building B14 Xiamen Biomedical Industrial Park 2076 Wengjiao West Road Haicang District Xiamen

Xiamen
361026

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
11/01/202118667
Guangdong Hecin Scientific Inc.4F Building 1 #1 Ruifa Rd
Luogang District
Guangzhou
Guangdong 510530

China
SHARE INFO LTD14 Castle Walk

London-Stansted
CM24 8LY

England United Kingdom
06/08/202115112
Hangzhou Lifereal Biotechnology Co. Ltd.1st & 2nd Floor of Building 4 and 1st Floor of Building 3 No 21 Futai Road Zhongtai Street Yuhang District

Hangzhou
310000

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
08/11/202116467
Hologic Inc.10210 Genetic Center Drive

San Diego
CA 92121

United States
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom
03/11/201669
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom





11/09/201768
Inno-train Diagnostik GmbHNiederhoechstaedter Str 62

Kronberg
D 61476

Germany
Sussex Biologicals LtdUnit H7/H8 Swallow Enterprise Park
Lower Dicker
Hailsham
East Sussex BN27 4EL

England United Kingdom
04/06/202113153
iONEBIO Inc.#1007~1012 Seongnam central biz tower 314 Galmachi-ro Jungwon-gu

Seongnam-si
Gyeonggi-do 13201

South Korea
UPIN & Co UK37 fl One Canada Square Canary Wharf

London
London E14 5AA

United Kingdom
06/16/202010133
Jiangsu Bioperfectus Technologies Co Ltd3rd & 4th Floors of Building A(G19) 4th Floor of Building F(G14)
Ground Floor of Building G20 Shauiyu Village Fuye Village
Taizhou
Jiangsu 225300

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
03/21/202112238
KH Medical Co. Ltd.201 Jinwiseo-ro Jinwi-myeon

Pyeongtaek-si
Gyeonggi-do 17712

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

Oxford
OX1 2EP

England United Kingdom
05/07/202114540
LumiraDx UK Ltd.Unit 1 Block 5 Dumyat Business Park
Bond Street
Alloa
FK102PB

United Kingdom





12/31/99999941
M Monitor Inc.62 Seongseogongdan-ro 11-gil

Daegu Dalseo-gu
42713

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

Oxford
OX1 2EP

England United Kingdom
07/28/202115955
Merlin Biomedical (Xiamen) Co. Ltd.4th Floor Building B3 2054 West Wengjiao Rd.

Haicang
Xiamen 361028

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
04/07/202113061
MOBILE DETECT BIO INC120 Industrial Blvd

Sugar Land
TX 77487

United States
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
03/16/202112699
Nanjing Liming Bio-Products Co. Ltd.No.12 Huayuan Road

Nanjing Jiangsu
210042

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/09/202011119
Nanjing Vazyme Medical Technology Co. LtdFloor 1-3 Building C2 Red Maple Park of Technological Industry
Kechuang Road Economy &Technology Development Zone
Nanjing
Jiangsu 210038

China
London Meditech Limited117 Viglen House Alperton Lane

London
HA0 1HD

England United Kingdom
03/29/202112971
NeuMoDx Molecular1250 Eisenhower Pl Ann Arbor

Washtenaw
MI 48108-3281

United States
QIAGEN Manchester LtdQIAGEN Manchester Ltd Citylabs 2.0
Hathersage Road
Manchester
M13 0JH

England United Kingdom
03/30/202113041
Nonacus LimitedBioHub Birmingham Research Park 97 Vincent Drive

Birmingham
West Midlands B15 2SQ

United Kingdom





12/31/999911077
OptiGene LimitedUnit 5 Blatchford Rd

Horsham
West Sussex RH13 5QR

United Kingdom





12/31/999910323
OptiGene LimitedUnit 5 Blatchford Rd

Horsham
West Sussex RH13 5QR

United Kingdom





12/31/999910323
Oxford MEStar LtdCentre For Innovation & Enterprise Begbroke Science Park
Begbroke Hill
Kidlington
Oxfordshire OX5 1PF

England United Kingdom





08/07/20188020
Oxford Nanopore Diagnostics LtdGosling Building Edmund Halley Road
Oxford Science Park
Oxford
Oxfordshire OX4 4DQ

United Kingdom





12/31/999910622
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
Primerdesign LtdUnit 1 Watchmoor Point Watchmoor Road Camberley Surrey

Camberley
GU15 3AD

United Kingdom





08/04/20176351
Primerdesign LtdUnit 1 Watchmoor Point Watchmoor Road Camberley Surrey

Camberley
GU15 3AD

United Kingdom





08/04/20176351
QIAGEN GmbHQIAGEn GmbH
Qiagen Str. 1 Hilden
Mettmann
Düsseldorf 40724

Germany
QIAGEN Manchester LtdQIAGEN Manchester Ltd Citylabs 2.0
Hathersage Road
Manchester
M13 0JH

England United Kingdom
03/19/202112724
QuantuMDx Group LtdLugano Building 57 Melbourne Street

Newcastle upon Tyne
NE1 2JQ

United Kingdom





12/31/99999764
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
Sansure Biotech Inc.No. 680 Lusong Road Yuelu District

Changsha
Hunan Province 410205

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/28/202117610
Shanghai Cagenbio Science Co. LtdRm.320 Building 5 No.185 East Jiangtian Road Songjiang District

Shanghai
201613

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
04/21/202113354
Shenzhen Huizhong Biotech Co. Ltd.B1 Xia Gu 101 Fengyeyuan Industrial Factory Xingdong Community
Xin'an Sub-district Bao'an District
Shenzhen
518101

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
09/21/202116707
SolGent Co. Ltd.43-10 Techno 5-ro Yuseong-gu

Daejeon
34014

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

Oxford
OX1 2EP

England United Kingdom
07/28/202116063
The Doctors Laboratory LimitedThe Halo Building 1 Mabledon Place

London
WC1H 9AX

England United Kingdom





12/31/999912027
Trentron Biomedical Ltd.(Building A) 35F. No.99 Sec.1 Xintai 5th Road

New taipei city
Xizhi District 22175

Taiwan
Advena LtdPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom
10/15/202118086
Vircell S.L.Parque Tecnológico de la Salud Avicena 8

Granada
18016

Spain
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
07/28/202115979
VivaChek Biotech (Hangzhou) Co. Ltd.Level 2 Block 2 146 East Chaofeng Rd. Yuhang Economy Development Zone

Hangzhou
Zhejiang 311100

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/06/202112650
Winnoz Technology Inc5F-1 No 238 Liancheng Road

New Taipei City
Zhonghe Dist 235

Taiwan
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
05/11/202114408
Wizbiosolutions Inc.A-802 Woolim Lions Valley 2 Sagimakgol-ro 45beon-gil 14 Jungwon-gu

Seongnam
13209

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

Oxford
OX1 2EP

England United Kingdom
06/02/202115030
Xi'an Tianlong Science and Technology Co. Ltd.Zhuhong Road National Economic and Technological Development Zone
No:389
Xi'an City
Shaanxi Province 710018

China
MCT Lifesciences LtdInnovation Centre Unit 24 Cranfield University Technology Park

Bedford
MK43 0BT

England United Kingdom
06/11/202115250
Xiamen Jiqing Biomedical Technology Co. Ltd.Unit 03 Level 3 Building 2 Haicang biomedical industrial park 2052 Weng Jiao West Road Haicang District

Xiamen
Fujian 361027

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
10/12/202117557
YOURGENE HEALTH UK LTDCitylabs 1.0 Nelson Street

Manchester
M13 9NQ

United Kingdom





09/13/20176929
YouSeq Limited8 Moorside Place Moorside Road

Winchester
SO23 7FX

England United Kingdom





12/31/999912389
Zhengzhou Fortune Bioscience Co. Ltd.(Fangxin Industrial Park) East Wansan Road North Shangdu Street Zhongmu County

Zhengzhou Henan Province
451450

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
06/26/202010194