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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
BeneCheck Supreme 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
Handheld DOA Reader
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Portable Incubator
Shenzhen Superbio Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Epithod®616 Analyzer
DxGen Corp.
·
,
South Korea
Class A
CE/IVDR
Fluorescence Immunoassay Analyzer
Shenzhen Drawray Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Portable Quantitative Immunoassay Analyzer
Hangzhou Realy Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Uni Premium Harnsäure-Messsystem
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Handheld Fluorescence Immunoassay Analyzer
Shenzhen Drawray Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Qassay Lateral Flow Reader DUAL
P4Q Health S.L.
·
,
Spain
Class A
CE/IVDR
Dry Fluorescence Immunoassay Analyzer
Suzhou Helmen Precision Insturments Co., Ltd
·
,
China
Class A
CE/IVDR
Colloidal Gold Test Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
Semi-Automatic Fluorescence Immunassay Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Mission Cholesterol Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Pathfast Waste Box
Phc Corporation
·
,
Japan
Class A
CE/IVDR
G6PD Biosensor Test Meter
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
Mini Immunofluorescence Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
ProciseDx Analyzer
ProciseDx Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Safe AQ UG
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
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