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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
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Diabetes monitoring
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Blood glucose meters
Blood glucose meters
W0201060102
313 devices
On Call Sure Sync Blood Glucose Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Blood Glucose Meter
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
EasyMax Voice Self Monitoring Blood Glucose System
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Blood Glucose and β-ketone Meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
Blood Glucose Monitoring System
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring system
Sejoy Biomedical Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
OneTouch SelectPlus
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
GLUCOCARD S onyx (GT-7120)
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
SOMA® be Blood Glucose Meter
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
EasyMax MU Self Monitoring Blood Glucose System [EN]
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
FDA 510(k)
K121207
Active
Cleared 18 May 2012
CE/IVDD
OGCare Kit - ENG
Biochemical Systems International S.p.A.
·
,
Italy
IVD Annex II List B
CE/IVDD
Blood Glucose Meter
Jiangxi Aicare Medical Technology Co., Ltd
·
,
China
IVD Annex II List B
CE/IVDD
GLUCO TEST Plus 10 Set mmol/l Messgerät
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Multi-functional Monitoring Meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
On Call Extra Blood Glucose Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
GLUCOCARD S onyx (GT-7120)
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
GlucoX Blood Glucose Monitoring System
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
×2
K190579
Active
Cleared 4 Jun 2019
CE/IVDD
ELEMENT 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
EasyMax Neu Self Monitoring Blood Glucose System
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
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