Manufacturer's By Device SARS-CoV-2 antigen IVD kit rapid ICT clinical-SARS-CoV-2 antigen IVD kit rapid ICT clinical

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
3B BlackBio Biotech India Limited7-C Industrial Area Govindpura

Bhopal Madhya Pradesh
462023

India
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/06/202120343
Abbott Rapid Diagnostics Jena GmbHOrlaweg 1

Jena
Thuringia 07743

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

England United Kingdom
03/15/202112662
Abbott Rapid Diagnostics Jena GmbHOrlaweg 1

Jena
Thuringia 07743

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

England United Kingdom
03/15/202112662
ACON Biotech (Hangzhou) Co LtNo 210 Zhenzhong Road West Lake District

Hangzhou
310030

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202211766
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO. LTD4th Floor D-1# Zone Pearl Industrial Park 106 Innovation Avenue High-Tech Development Zone

Hefei
Anhui 230088

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202212384
AnteoTech LtdUnit 4 26 Brandl Street Eight Mile Plains

Brisbane
Queensland 4113

Australia
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
03/28/202217528
Beijing Beier Bioengineering Co. Ltd.No.99 Chuangxin Road Lucheng Industral Development Zone
Huangcun Town Daxing District
Beijing
102612

China
IMed Consultancy Ltd Bloxham Mill Business centre Barford Road
Bloxham
Banbury
OX154FF

England United Kingdom
04/25/202224334
Beijing Unidiag Technology Inc.Tower 10-208 No.09 Tianfu Ave China Bio-medicine Industry Park Daxing District

Beijing
102600

China
NPZ technology LtdStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE

United Kingdom
05/05/202114468
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom





03/02/20209656
Birmingham Biotech LTDBirmingham Research Park 97 Vincent Drive

Birmingham
B15 2SQ

England United Kingdom





12/07/202011084
Chil Tbbi Mal. San. ve Tic. Ltd. ti.10028 Sok. No:11 AOSB 35620 Çili zmir
10028 Sok. No:11 AOSB 35620 Çili zmir
zmir
Çili 35620

Turkey
Offsure Navigation LTD13 Poplar Grove

Pontefract
West Yorkshire WF8 4AZ

England United Kingdom
08/31/202219132
Core Technology Co. Ltd.Room 100 C Building No.29 Life Park Rd. Changping District

Beijing
102206

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/24/202011242
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
Draeger Safety AG & CoRevalstraße 1

Lübeck
23560

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

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
03/11/202112609
Draeger Safety AG & CoRevalstraße 1

Lübeck
23560

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

hemel hempstead
Hertfordshire HP2 7BW

England United Kingdom
03/11/202112609
Edinburgh Genetics Limited64a Cumberland Street

Edinburgh
EH3 6RE

Scotland United Kingdom
EG GENETICS LIMITEDMoat House 54 Bloomfield Ave

Belfast
BT5 5AD

Northern Ireland United Kingdom
04/15/202211340
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
Guangzhou Biotron Technology Co. Ltd.Room 301& 401 Building C6 No. 11 Kaiyuan Road Huangpu District

Guangzhou Guangdong
510663

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
03/29/202212900
Guangzhou KoFa Biotechnology Co. Ltd.5F/6F Building C4 No.11 Kaiyuan Avenue Science City

Guangzhou City Guangdong
510530

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
03/03/202212425
Guangzhou Wondfo Biotech Co. Ltd.No.8 Lizhishan Road Science City Luogang District

Guangzhou
510663

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
03/07/202112536
Hangzhou Alltest Biotech Co Ltd#550 Yinhai Street Hangzhou Economic & Technological Development Area

Hangzhou
310018

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202212580
Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd.Bldg. 2 No. 568 Binkang Rd. Binjiang Dist.

Hangzhou
Zhejiang 310052

China
NPZ technology LtdStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE

United Kingdom
03/29/202112385
Humasis Co. Ltd.Rm.114 502 504 604 604-1 B03-01 B03-02 88 Jeonpa-ro Dongan-gu

Anyang-si
Gyeonggi-do 14042

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

Oxford
OX1 2EP

England United Kingdom
06/22/202115215
Inzek International Trading BVVissenstraat 32

Apeldoorn
Provincie Gelderland 7324 AL

Netherlands
Dawn Asset Management LimitedKalamu House Coldbath Square

London
EC1R 5HL

England United Kingdom
04/20/202216090
Kangmei Tianhong Biotech (Beijing) Co. Ltd. #16 No.1 Gaolizhang Road

Haidian Beijing
100095

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
01/10/202221131
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
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
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
Rapid Labs LtdUnit 2 & 2a Hall Farm Business Centre

Colchester
Essex CO7 8SD

United Kingdom





11/29/20199366
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
Sekisui Diagnostics LLC6659 Top Gun Street

San Diego
CA 92121

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

England United Kingdom
01/11/202221242
Shenzhen Lvshiyuan Biotechnology Co. Ltd.D Building No.2 Industrial Avenue Buxin Village Buxin Community Dapeng Subdistrict Office Dapeng New District Shenzhen 518120 China

Shenzhen
518120

China
PureUKCA Ltd59 St. Martin's Lane

London
Middlesex WC2N 4JS

England United Kingdom
04/14/202218481
Weihai Kangzhou Biotechnology Engineering Co. Ltd.Room 401 Building B Innovation Entrepreneurship Base High District Weihai City

Shandong Province
264205

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
02/25/202112338
Wuhan UNscience Biotechnology Co. LtdBuilding B18 2nd Phase of Biomedical Park #858 GaoXin Road Donghu Hi-Tech Development

Wuhan
Hubei 430070

China
NPZ technology LtdStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE

United Kingdom
04/21/202113628
Xiamen Biotime Biotechnology Co. Ltd.2F/3F/4F/5F No.188 Pingcheng South Road Haicang District

Xiamen
Fujian 361026

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202210710
Xiamen Biotime Biotechnology Co. Ltd.2F/3F/4F/5F No.188 Pingcheng South Road Haicang District

Xiamen
Fujian 361026

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202210710
Xiamen Boson Biotech Co. Ltd.90-94 Tianfeng Road Jimei North Industrial Park

Xiamen
Fujian 361021

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202210786
Xiamen Boson Biotech Co. Ltd.90-94 Tianfeng Road Jimei North Industrial Park

Xiamen
Fujian 361021

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202210786
Zhejiang Quark Biological Technology Co. Ltd.No.1 Jiangdong Road Zhejiang Xinchang High-tech Industrial Park

Shaoxing Xinchang District Zhejiang
312500

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/30/202011214
Zhuhai Livzon Diagnostics Inc.No. 266 Tongchang Road Xiangzhou District

Zhuhai
Guangdong 519060

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
11/01/202118694