Manufacturer's By Device Glucose monitoring system IVD home-use-Glucose monitoring system IVD home-use, Glucose monitoring system IVD home-use Conformity Assessment Certificate Expired

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diabetes Care LtdRange Road

Witney
OX290YL

England United Kingdom





10/31/20199196
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
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
AEON DIAGNOSTIC Technology Corporation1F. No. 24 Ln. 73 Rongxing Rd. Bade Dist.

Taoyuan City
33463

Taiwan
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
09/16/202226025
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
ARKRAY Factory Inc.1480 Koji Konan-cho
Koka-shi
Shiga
520-3306

Japan
Arkray LtdBeacon House Ibstone Road
Stokenchurch Business Park
High Wycombe
Buckinghamshire HP14 3FE

England United Kingdom
08/06/202116431
Bionime Corporation100 Sec. 2 Daqing St. South Dist.

Taichung City
40242

Taiwan
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
02/01/202221656
Changsha Sinocare Inc.No. 265 Guyuan Road Hi-tech Zone Changsha

Hunan Province
410205

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
05/29/202114945
ForaCare Suisse AGNeugasse 55

St. Gallen
9000

Switzerland
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202217896
General Life Biotechnology Co. Ltd.6 7F. No. 669 Jhongjheng Rd. Shin Juang Dist.

New Taipei City
242

Taiwan
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
01/24/202222172
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 Sejoy Electronics & Instruments Co. Ltd.Area C Building 2 No. 365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City

Zhejiang Province
311100

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
07/09/202115779
Hygieia Inc.28803 8 Mile Rd.

Livonia
MI 48152

United States
QNET LtdLivingstone House 309 Harrow Road

Wembley
Middlesex HA9 6BD

England United Kingdom
12/29/202121610
i-SENS Inc.43 Banpo-daero 28-gil Seocho-gu

Seoul
06646

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

Oxford
OX1 2EP

England United Kingdom
07/27/202116302
LifeScan Europe GmbHGubelstrasse 34

Zug
6300

Switzerland
LifeScan Scotland LimitedBeechwood Park North

Inverness
Inverness-Shire IV2 3ED

Scotland United Kingdom
11/09/202119334
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
National Diagnostic Products (Australia) Pty LtdNational Diagnostic Products (Australia) Pty Ltd Suite 503 7-9 Merriwa Street

Gordon
NSW 2072

Australia
BETACHEK (UK) LIMITED7 Bell Yard

London
WC2A 2JR

England United Kingdom
11/16/202118389
OK Biotech Co. Ltd.No. 91 Sec. 2 Gongdao 5th Rd.

Hsinchu City
30070

Taiwan
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
01/06/202221056
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
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
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
Trividia Health Inc.2400 NW 55th Court

Fort Lauderdale
Florida 33309

United States
Trividia Health UK Limited 27 Old Gloucester Street

London
WC1N 3AX

England United Kingdom
06/18/202115327
URIT Medical Electronic Co. Ltd.No.D-07 Information Industry District High-Tech Zone

Guilin Guangxi
541004

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
02/05/202111972
Visgeneer Inc.No.335 Sec.6 Zhonghua Rd.

Hsinchu City
30094

Taiwan
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
11/30/202120227
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
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