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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
Blood Glucose Test Strip
Cofoe Medical Technology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
ConfiGlu G1 Blood Glucose Test Strip
Genbody Inc.
·
,
South Korea
Class C
CE/IVDR
IX 2631406-2
Active
Valid to May 2031
GLUCOCARD W Test Strips
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
GlucoLeader Enhance Blood Glucose Test Strip
Hmd Biomedical Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Blood Glucose Test Strips
Beijing Lepu Medical Technology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
OneTouch Verio test strip
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Blood Glucose Test Strip
Changsha Sinocare Inc.
·
,
China
IVD for self-testing
CE/IVDD
GlucoMen areo GK
A. MENARINI Diagnostics S.r.l.
·
,
Italy
IVD Annex II List B
CE/IVDD
Glucofix Tech Gk
A. MENARINI Diagnostics S.r.l.
·
,
Italy
IVD Annex II List B
CE/IVDD
GlucoSure Autocode
Apex Biotechnology Corp.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
On Call Sure Sync Blood Glucose Monitoring System
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Linksun Blood Glucose Monitoring System
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
Accu-Answer
Guilin Zhonghui Technology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
On Call Sure Blood Glucose Monitoring System
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
FDA 510(k)
K181527
Active
Cleared 3 Oct 2018
CE/IVDD
Glucofix Tech
A. MENARINI Diagnostics S.r.l.
·
,
Italy
IVD Annex II List B
CE/IVDD
GlucoMen areo
A. MENARINI Diagnostics S.r.l.
·
,
Italy
IVD Annex II List B
CE/IVDD
Linksun Blood Glucose Monitoring System
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
FDA 510(k)
K191657
Active
Cleared 20 Mar 2020
Linksun Blood Glucose Monitoring System
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
Blood Glucose Monitoring System
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
Ap-10
Leison Biotech Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
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