Manufacturer's By Device Glucose IVD reagent-Glucose IVD reagent, Glucose IVD reagent Conformity Assessment Certificate Expired

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Page(s) 1
Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
AgaMatrix Inc.7C Raymond Avenue

Salem
New Hampshire 03079

United States
AgaMatrix Europe LimitedHarwell Innovation Centre 173 Curie Avenue
Harwell Oxford
DIDCOT
Oxfordshire OX11 0QG

England United Kingdom
06/27/202217920
All Medicus Co. Ltd.#7102~7107 #7402 #7403 #7406 140 Beolmal-ro Dongan-gu Anyang-si Gyeonggi-do 14057 REPUBLIC OF KOREA

Dongan-gu Anyang-si
Gyeonggi-do 14057

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

Oxford
OX1 2EP

England United Kingdom
06/08/202115214
Andon Health Co LtdNo 3 Jinping Street YaAn Road Nankai District

Tianjin
300190

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202215775
Apex Biotechnology Corp.No. 7 Li-Hsin Rd. V Hsinchu Science Park

Hsinchu City
300094

Taiwan
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
01/18/202221305
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Cliniqa Corporation495 Enterprise Street

San Marcos
California 92078

United States
UKCApartner4U Limited7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom
06/13/202224799
e-LinkCare Meditech Co. Ltd.No.30 Baita Tongjiang Road

Taizhou Zhejiang
317317

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
09/01/202010509
ForaCare Suisse AGNeugasse 55

St. Gallen
9000

Switzerland
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202217896
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
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
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
Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd.No. 8 Shengchang West Road Danyang Development Zone

Jiangsu Province
212300

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
11/29/202119036
MiCo BioMed Co. Ltd.116 Gongdan 1-ro

Anseong-si
Gyeonggi-do 17575

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

Oxford
OX1 2EP

England United Kingdom
07/14/202115954
Nova Biomedical Corporation200 Prospect Street

Waltham
MA 02454-9141

United States
Nova Biomedical CorporationInnovation House Aston Lane South
Runcorn
Runcorn
Cheshire WA7 3FY

England United Kingdom
05/18/202217568
Ortho-Clinical Diagnostics Inc.100 Indigo Creek Drive

Rochester
New York 14626

United States
Ortho-Clinical DiagnosticsFelindre Meadows Pencoed

Bridgend
CF35 5PZ

Wales United Kingdom
12/04/20157248
OSANG Healthcare Co. Ltd.132 Anyangcheondong-ro Dongan-gu

Anyang-si
Gyeonggi-do 14040

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
10/04/202117967
Prestige Diagnostics U.K. Ltd65 Fenaghy Road Galgorm

Ballymena
County Antrim BT42 1HW

Northern Ireland United Kingdom





07/21/20157207
Roche Diabetes Care GmbhSandhofer Strasse 116

Mannheim
68305

Germany
Roche Diabetes Care Ltd.Charles Avenue Burgess Hill RH15 9RY

Burgess Hill
RH15 9RY

United Kingdom
02/09/202112063
Roche Diagnostics GmbHSandhofer Strasse 116

Mannheim
68305

Germany
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/19/202113524
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

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

Oxford
OX1 2EP

England United Kingdom
05/11/202114605
SENTINEL CH. S.p.A.Via Robert Koch 2
Milano
MI
Lombardia 20152

Italy
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
08/10/202116678
SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH1F No.8 Dusing Rd. Hsinchu Science Park East Dist.

Hsinchu City
30078

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

Oxford
OX1 2EP

England United Kingdom
03/11/202223557
TaiDoc Technology CorpB1-7F No 127 Wugong 2nd Road

New Taipei City
Wugu Dist 24888

Taiwan
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202218410
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
Zhejiang PushKang Biotechnology Co. Ltd.C408 Science and Technology Innovation Park No. 398 Mahuan Road Binhai New Area Shaoxing

Zhejiang Province
312366

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
11/17/202226967