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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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Various rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)
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Various rapid test chemistry / immunochemistry instruments - other
Various rapid test chemistry / immunochemistry instruments - other
W0201069099
235 devices
Multiplex Fluorescent Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Microlife Multiplex Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
AllDx
Hangzhou Aokai Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Chemiluminescence Immunoassay Analyzer
Nanjing Poclight Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip)
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD for self-testing
CE/IVDD
BeneCheck Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
BeneCheck Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Uric Acid Meter
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class A
CE/IVDR
Nemesys
A.S.T. s.r.l.
·
,
Italy
Class A
CE/IVDR
Mini Immunofluorescence Analyzer
Healgen Scientific Limited Liability Company
·
,
United States
Class A
CE/IVDR
Compass3000-2
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Colloidal gold immunochromatography reader
Suzhou Helmen Precision Insturments Co., Ltd
·
,
China
Class A
CE/IVDR
VivaDiag Plus
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
QUIK-CHECK Ultra Cholesterol Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Getein 1160 Immunofluorescence Quantitative Analyzer
Getein Biotech, Inc
·
,
China
IVD General
CE/IVDD
Rapid Test Reader
KAIWOOD Technology Co., Ltd.
·
,
Taiwan
Class A
CE/IVDR
Compass3000-1
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
QUIK-CHECK Cholesterol Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Multi-channel Immunofluorescence Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Fully Automatic Biochemistry Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
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