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In vitro diagnostic medical devices
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IVD instruments
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Chemistry / immunochemistry instruments
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Chemistry / immunochemistry rapid tests + poc tests
Chemistry / immunochemistry rapid tests + poc tests
W020106
681 devices
Subcategories
2
W02010601
Diabetes monitoring
410
devices
›
W02010690
Various rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)
271
devices
›
Devices
Blood Glucose and Lactate Meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
Safe-Accu
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
Dcont ROLL
77 Elektronika Műszeripari Kft
·
,
Hungary
Class C
CE/IVDR
IX 1006099-1
Active
Valid to Feb 2031
Safe-Accu2
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
GLUCO TEST DUO Pro Set Blutzuckermessgerät mg/dl
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
OGCare Kit - Free Sample - Kit
Biochemical Systems International S.p.A.
·
,
Italy
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring System
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
OGCare Kit (mmol/L) - ENG
Biochemical Systems International S.p.A.
·
,
Italy
IVD Annex II List B
CE/IVDD
EasyMax MU Self Monitoring Blood Glucose System
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Blood Glucose Meter
Changsha Sinocare Inc.
·
,
China
IVD for self-testing
CE/IVDD
Aria Kit
Biochemical Systems International S.p.A.
·
,
Italy
IVD Annex II List B
CE/IVDD
SOMA® be Self Monitoring Blood Glucose System
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Simcheck
Scienco Technology Corp.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip)
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD Annex II List B
CE/IVDD
GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
Blood Glucose Meter
Cofoe Medical Technology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring System
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
OneTouch SelectPlus
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
ConfiGlu G1 Blood Glucose Meter Set
Genbody Inc.
·
,
South Korea
Class C
CE/IVDR
IX 2631406-2
Active
Valid to May 2031
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