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In vitro diagnostic medical devices
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Clinical chemistry
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Clinical chemistry - rapid tests & poc
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Blood test strips (cc) - rt & poc
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Glucose test strips
Glucose test strips
W0101060101
361 devices
RIGHTEST Wiz Plus Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
K173139
Active
Cleared 19 Jun 2018
CE/IVDD
GE Blood Glucose Monitoring System GE100
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST GM110 Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Blood Glucose Monitoring System GM720
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Blood Glucose Monitoring System GM280B
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Blood Glucose Monitoring System GM700SB
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Max Plus Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Brisa Plus Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST ALPHA Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Sol Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
GE Blood Glucose Monitoring System GE200
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Alma Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Rightest Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
K120423
Active
Cleared 3 Aug 2012
CE/IVDD
RIGHTEST Blood Glucose Monitoring System GM260
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST GT333 Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Glucocard W (Gt-7210)
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
OKmeter Match Premium Blood Glucose Monitoring System
Ok Biotech Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Glucocard W (Gt-7210)
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
RIGHTEST Brisa Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Glucocard W (Gt-7210)
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
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