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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
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
EasyMax Voice Self Monitoring Blood Glucose System
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Blood Glucose Meter
Bioland Technology Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
GUDID
on market
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
FIABiomed Precisa Blood Glucose Monitoring System
Hmd Biomedical Inc.
·
,
Taiwan
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) - HU
Biochemical Systems International S.p.A.
·
,
Italy
IVD Annex II List B
CE/IVDD
OneTouch Select Plus Flex
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
plusMED fasTTest
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Dcont ETALON Kit
77 Elektronika Műszeripari Korlátolt Felelősségű Társaság
·
,
Hungary
Class IIa
CE/MDR
Multi-functional Monitoring Meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
On Call Sure Blood Glucose Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Next SYSTÉM NA MONITOROVANIE GLUKÓZY V KRVI
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
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