Manufacturer's By Device General specimen collection kit IVD-

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Page(s)
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
Access Genetics LLC7400 Flying Cloud Drive Suite 150

Eden Prairie
Minnesota 55344

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

Northern Ireland United Kingdom
05/12/202224609
Agendia N.V.Radarweg 60

Amsterdam
1043 NT

Netherlands
Qserve Group UK Ltd. 49 Greek Street

London
W1D 4EG

England United Kingdom
05/12/202224603
Becton Dickinson and Company (BD)7 Loveton Circle

Sparks
Maryland 21152

United States
Becton Dickinson U.K. Limited1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom
09/09/202117321
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
Bsure Medical BVAchillesstraat 85 Amsterdam

Amsterdam
Provincie Noord-Holland 1076 PX

Netherlands
Fagron UK LtdMedia Exchange 4b Coquet Street

Newcastle Upon Tyne
NE1 2QB

United Kingdom
04/11/202224161
Cepheid Inc904 Caribbean Drive

Sunnyvale
CA 94089

United States
Cepheid UK LtdOakley Court Kingsmead Business Park
Frederick Place
High Wycombe
HP11 1JU

England United Kingdom
12/23/202121497
Chronomics LimitedBizSpace Wimbledon 8 Lombard Road

London
SW19 3TZ

England United Kingdom





02/25/202112347
Copan Italia S.p.A.Via F. Perotti 10

Brescia
25125

Italy
Qserve Group UK Ltd. 49 Greek Street

London
W1D 4EG

England United Kingdom
04/15/202215928
Dynamic Code ABFridtunagatan 24

Linköping
Östergötland SE58213

Sweden
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
01/24/202221681
E & O Laboratories LtdBurnhouse

Scotand
Bonnybridge FK4 2HH

United Kingdom





02/06/20046933
General Biologicals CorporationNo.6 Innovation First Road Hsinchu Science Park
Baoshan Township Hsinchu County 30076
Taiwan R.O.C
30076

Taiwan
FREYR LIFE SCIENCES LTD1 Bell Street

Maidenhead
Berkshire SL6 1BU

England United Kingdom
11/01/202118725
GRAIL LLC1525 O'Brien Drive

Menlo Park
California 94025

United States
GRAIL BIO UK Ltd.New Penderel House 4th Floor 283-288 High Holborn

London
WC1V 7HP

England United Kingdom
06/24/202115491
HiMedia Laboratories Private Ltd.Plot No. C-40 Road No. 21/Y MIDC
Wagle Industrial Area
Thane (West)
Maharashtra 400 604

India
UKCApartner4U Limited7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom
02/07/202222045
Hinpack LtdManor Farm Grain Store Gravel Pit Hill
Thriplow
Royston
Hertfordshire SG8 7HZ

England United Kingdom





04/15/202210819
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
Huachenyang (Shenzhen) Technology Co. Ltd.Area A F8/Bldg 4 Hengchangrong High Tech Park Shangnan East Road
Hongtian Shajing. Baoan
Shenzhen
Guangdong 518125

China
SHARE INFO LTD3rd Floor Office C Townend House Park Street

Walsall
West Midlands WS1 1NS

England United Kingdom
03/31/202223815
Invitae Corporation1400 16th Street

San Francisco
CA 94103

United States
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
02/22/202223155
Jiangsu Hanheng Medical Technology Co. Ltd.16-B4 #1 North Qingyang Road Tianning District Changzhou

Jiangsu Province
213017

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
11/03/202118521
Jiangsu HXRT MD Co. LtdNo. 66 Xingyuan Road The Modern Science and Technology Industrial Area Jiangyan District

Taizhou
225530

China
KINGSMEAD SERVICE LIMITED19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ

England United Kingdom
10/15/202118236
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
JINAN BABIO BIOTECHNOLOGY CO. LTD.303 Building 5 of SME Industrialization Base of Biomedical Park 1777 Dazheng Road High-tech Zone Jinan City 250101 Shandong Province China

Jinan
Shandong 250101

China
PureUKCA Ltd59 St. Martin's Lane

London
Middlesex WC2N 4JS

England United Kingdom
04/14/202215080
Life Science Group LtdUnit 14 Crowhill Farm Ravensden Road

Wilden
MK44 2QS

United Kingdom





11/11/202010802
Medical Wire & Equipment Co Bath (Ltd)Potley lane

Corsham
SN13 9RT

United Kingdom





01/09/20209489
Medical Wire & Equipment Co Bath (Ltd)Potley lane

Corsham
SN13 9RT

United Kingdom





01/09/20209489
Medical Wire & Equipment Co Bath (Ltd)Potley lane

Corsham
SN13 9RT

United Kingdom





01/09/20209489
Meridian Bioscience Inc.3471 River Hills Drive

Cincinnati
OH 45244

United States
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
09/08/202117346
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
Oncologica UK LimitedSuite 2 Newnham Building Chesterford Research Park
Little Chesterford
Cambridge
CB10 1XL

England United Kingdom





11/05/202119870
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
Remel Inc12076 Santa Fe Trail Drive

Lenexa
Kansas 66215

United States
Oxoid LimitedWade Road

Basingstoke
RG24 8PW

England United Kingdom
11/15/202119041
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
Shandong ThinkLab Biotechnology Co. Ltd.No.1 Building No.10 Industrial Park Jining Hi-tech Zone

Jining Shandong
272000

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/16/202211624
Shenzhen Dakewe Bio-engineering Co. Ltd.Room 702-703 Building No.1 Shenzhen Biomedicine Innovations Industrial Park No.14 Jinhui Road Kengzi Street Pingshan District

Shenzhen Guangdong
518122

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202223766
Technical Service Consultants LtdMicrobiology House Fir Street

Heywood
Ol10 1NW

England United Kingdom





01/04/202111355
UK Health Security AgencyUK Health Security Agency Nobel House
17 Smith Square London
London
SW1P 3HX

England United Kingdom





08/27/202010497
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
Zymo research corp17062 MURPHY AVENUE

IRVINE
92614

United States
North Wald LimitedLytchett Matravers Unit13 Freeland Park Wareham Road

Poole
Dorset BH16 6FA

England United Kingdom
02/22/202223177