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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
lisubel®check LB-EMV3 Blood Glucose Meter
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Blood Glucose Meter
YASEE BioMedical Inc.
·
,
China
IVD for self-testing
CE/IVDD
Glucómetro
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
OneTouch Verio Reflect
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
SEJOY Blood Glucose Monitoring System
Sejoy Biomedical 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
Dcont ETALON
77 Elektronika Műszeripari Kft
·
,
Hungary
Class C
CE/IVDR
IX 1006099-1
Active
Valid to Feb 2031
BeneCheck Supreme Blood Glucose Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Meter
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
CE/IVDD
+1
authorizations
familyDr.™ Blood Glucose Monitoring System
All Medicus Co., Ltd.
·
,
South Korea
Class C
CE/IVDR
OneTouch SelectPlus
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Multi-functional Monitoring Meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
OneTouch SelectPlus
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
CERA-CHEK™ 1070 Blood Glucose Monitoring System
GC MEDIS Corp.
·
,
South Korea
IVD Annex II List B
CE/IVDD
Handheld electrochemical meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
lisubel®check LB-EMV3 Self Monitoring Blood Glucose System
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Blood Glucose Meter
URIT Medical Electronic 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
Ap-10
Leison Biotech Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
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