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In vitro diagnostic medical devices
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Clinical chemistry
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Clinical chemistry - rapid tests & poc
Clinical chemistry - rapid tests & poc
W010106
2,150 devices
Subcategories
6
W01010601
Blood test strips (cc) - rt & poc
839
devices
›
W01010602
Urine testing (cc) - rt & poc
982
devices
›
W01010603
Faeces tests (cc) - rt & poc
82
devices
›
W01010604
Multiple parameters poc
45
devices
›
W01010606
Electrodes or cassettes for blood gas analysis incl. electrolytes / metabolites - poc
163
devices
›
W01010699
Clin. chem. rt & poc - other
39
devices
Devices
On Call Extra Blood Glucose Monitoring System
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
On Call Plus Blood Glucose Monitoring System
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
ACEZIN AMIGold mini Blood Glucose Monitoring System
Ace Medical Technology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring System
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
Wellion AMADEUS
Apex Biotechnology Corp.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Monitoring System
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
On Call EZ II Blood Glucose Monitoring System
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
K173638
Active
Cleared 17 Aug 2018
CE/IVDD
Rightest Blood Glucose Meter GM700 Pro
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 Blood Glucose Monitoring System GM700S
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
K190564
Active
Cleared 2 Jun 2019
CE/IVDD
RIGHTEST Blood Glucose Monitoring System GM700 Pro 2
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST ELSA Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Max Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Blood Glucose Monitoring System GM300
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
×2
K042678
Active
Cleared 3 Jan 2005
CE/IVDD
RIGHTEST Sol Plus Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Mylife Unio Cara Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Wiz Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST GM100 Blood Glucose Monitoring System
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
RIGHTEST Blood Glucose Monitoring System GM700
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
×3
K140210
Active
Cleared 22 Aug 2014
CE/IVDD
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