Manufacturer's By Device SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid-SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
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
ADS Biotec Inc7409 Irvington Road
40 Watt Road
Omaha
NE 68122

United States
EU-UK Authorised Representative LtdUnit 591 Moat House
54 Bloomfield Avenue
Belfast
BT5 5 AD

Northern Ireland United Kingdom
04/19/202113519
Boditech Med Inc43 Geodudanji 1-Gil Chuncheon-Si Chuncheon-Si

Gangwon-Do
24398

South Korea
Phil and Adams Limited2 Mannin Way

Lancaster
LA1 3SU

United Kingdom
02/13/202112137
Chongqing iSIA BIO-Technology Co. LtdNo. 388 Jingdongfang Avenue Beibei District

Chongqing
400714

China
Cylogene UK Limited253 Gray's Inn Road

London
WC1X 8QT

England United Kingdom
11/01/202118600
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
Genbody Inc3-18 Eopseong 2-gil
Seobuk-gu Cheonan-si
Chungcheongnam-do
312-800

South Korea
Phil and Adams Limited2 Mannin Way

Lancaster
LA1 3SU

United Kingdom
02/03/202111971
Green Cross Science Co. Ltd.107 Ihyeon-ro 30 beon-gil
Giheung-gu Yongin-si
Gyeonngi-do
16924

South Korea
Phil and Adams Limited2 Mannin Way

Lancaster
LA1 3SU

United Kingdom
08/23/202116823
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
03/28/202112580
LumiraDx UK Ltd.Unit 1 Block 5 Dumyat Business Park
Bond Street
Alloa
FK102PB

United Kingdom





12/31/99999941
Sanwa BioTech LimitedUnit 1-5 & 10-12 5/F Unit 3B 9/F Unit 7 12/F Wah Lai Industrial Centre 10-14 Kwei Tei Street Fo Tan Shatin New Territories

Hong Kong
00000

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
06/02/202115029
Shenzhen Microprofit Biotech Co. LtdRm. 405 406 Zone B /4F Rm. 205 206-1 207 West Side of Zone B/ 2F Haowei Building No. 8 Langshan 2nd Road
Songpingshan Songpingshan Community Xili Street Nanshan District
Shenzhen
518057

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
03/19/202112785