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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
Blood Glucose and β-ketone Meter
Eaglenos Sciences, Inc.
·
,
China
Class A
CE/IVDR
VivaChek Eco Blood Glucose Monitoring System
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
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
VivaChek Ino Blood Glucose Meter
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
OneTouch Verio Reflect
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
On Call Extra Blood Glucose Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
GLUCO TEST DUO Blutzuckermessger.Starterset mg/dl Messgerät
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Meter
YASEE BioMedical Inc.
·
,
China
IVD for self-testing
CE/IVDD
Rossmax
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Spengler JT100 Control Solution (Level 2) (CE)
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Slx-120
Changsha Sinocare Inc.
·
,
China
IVD General
CE/IVDD
BeneCheck Supreme Blood Glucose Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Safe AQ Voice
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
VivaChek FAD Blood Glucose Meter
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Wellion CALLA light, white, mmol/L
MED TRUST Handelsges.m.b.H.
·
,
Austria
Class I
CE/MDR
GLUCO TEST DUO Blutzuckermessger.Starterset mmol/l
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
4SURE Smart
ForaCare Suisse AG
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring System
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
206 Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Next PRO Glukomer
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
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