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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
Colloidal Gold Immunoassay Analyzer
Xiamen Boson Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Immunofluorescence Analyzer
Shenzhen Superbio Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Fluorescence Immunoassay Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
Handheld Fluorescence Immunoassay Analyzer
Shenzhen Drawray Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Blood Glucose and Uric Acid and Total Cholesterol Test Meter
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck PLUS Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Immunofluorescence Analyzer
Shenzhen Everbest Machinery lndustry Co., Ltd.
·
,
China
Class A
CE/IVDR
Immunofluorescence Reader
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Labpad Evolution
Biosynex
·
,
France
Class A
CE/IVDR
BeneCheck Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Colloidal gold immunochromatography reader
Suzhou Helmen Precision Insturments Co., Ltd
·
,
China
Class A
CE/IVDR
Dry Fluorescence Immunoassay Analyzer
Coei Biotech Co.Ltd.
·
,
China
Class A
CE/IVDR
STANDARD™ F200 Analyzer
Sd Biosensor, Inc.
·
,
South Korea
Class A
CE/IVDR
Fluorescence Immunoassay Analyzer
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
FIAPro™ Mobile Immunofluorescence Analyzer
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
Immunofluorescence Analyzer
Guangzhou Decheng Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Qassay Lateral Flow Reader Visible
P4Q Health S.L.
·
,
Spain
Class A
CE/IVDR
Portable Coagulation Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
iREAD
P4Q Health S.L.
·
,
Spain
Class A
CE/IVDR
Renal Function Analysis Meter
Hangzhou Lysun Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
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