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

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Aikang Diagnostics Co Ltd.501 Building 1&3 Hongxin Industrial Park
Guanguang Road 1303 Guanlan Longhua District
Guangdong
Shenzhen 518110

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202216334
Autobio Diagnostics Co. LtdNo. 87 Jingbei Yi Road National Eco & Tech Development Area

Zhengzhou
450016

China
Chirus LimitedGreenhill House 26 Greenhill Crescent
Watford Business Park
Watford
Hertfordshire WD18 8JA

England United Kingdom
09/01/202116792
Beijing Biosis Healing Biological Technology Co. LtdNo.6 plant west Valley No.1 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
07/27/202116186
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
Co-Innovation Biotech Co. Ltd.No.9 Baihe 3 Street Economic and Technological Development East Zone

Guangzhou
Guangdong 510530

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
03/19/202112765
Dewei Medical Equipment Co. Ltd5th Floor No.4 Building Shiyou Industrial Park Jun'an Shunde

Foshan
Guangdong 528329

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
05/27/202114012
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

Scotland United Kingdom
EG GENETICS LIMITEDMoat House 54 Bloomfield Ave

Belfast
BT5 5AD

Northern Ireland United Kingdom
04/15/202211340
Feng Chun Yuan Medical Equipment (Shenzhen) Co. Ltd.Room 1304 & Room 504 No.48 Xinyu Road Xiangshan Community Xinqiao Street
Baoan District
Shenzhen Guangdong
518000

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
12/09/202117980
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
Jiangsu Accuracy Biotechnology Co. Ltd.No. 8 Shengchang West Road Danyang Development Zone Danyang

Jiangsu Province
212300

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
01/16/202218898
Jiangsu Mole Bioscience Co. Ltd.6-7th Floor G116 Building No. 805 Jiankang Avenue Medical New & Hi-tech District Taizhou

Jiangsu Province
225300

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
03/05/202112478
Meril Diagnostics Pvt. Ltd.Second Floor D1-D3 Meril Park Survey No. 135/2/B & 174/2 Muktanand Marg Chala

Vapi
Gujarat 396191

India
Meril UK Limited2nd Floor 55 Ludgate Hill

London
EC4M 7JW

England United Kingdom
04/25/202224348
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
Mico BioMed Co. Ltd.3rd and 4th floor 54 changeop-ro Sujeng-gu Seongnam-si Gyeonggi do

Sujeng-gu Seongnam-si
13449

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/01/202225408
Neo-nostics (Suzhou) Bioengineering Co. Ltd.2F #3 Building #52 Yin Gang Road Taicang Suzhou City

Jiangsu Province
215434

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
06/22/202115322
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
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
Sensing Self Pte Ltd160 Robinson Road #20-03 Singapore Business Federation Ctr

Singapore
068914

Singapore
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
06/01/202115051
Shanghai Bionaire Biotech Co. Ltd.4F Building 1 No.105 Sinan Road Huangpu District

Shanghai
200025

China
KINGSMEAD SERVICE LIMITED19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ

England United Kingdom
11/05/202118726
SHENZHEN YHLO BIOTECH CO. LTD.Building 1 YHLO Biopark Baolong 2nd Road Baolong Subdistrict Longgang District

Shenzhen Guangdong
518116

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202216153
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
04/13/202212650
Weihai Dishang Medical Technology Co. LtdNo.220-5 Huoju Road Torch Hi-tech Industrial Development Zone

Weihai
Shandong 264200

China
KINGSMEAD SERVICE LIMITED19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ

England United Kingdom
10/25/202118453
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
Xiamen Hopegen Medical Technology Co. Ltd.Room 905 253 Duiying Nan Road Houxi Town Jimei District Xiamen

Fujian Province
361021

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
03/26/202112945
Zhongxiu Science and Technology Co. Ltd.Dingluan Industrial Zone Changyuan City

Henan Province
453400

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
05/26/202114960
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