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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
Dry Fluorescence Immunoassay Analyzer
Coei Biotech Co.Ltd.
·
,
China
Class A
CE/IVDR
AUTODXTM Analyzer
DxGen Corp.
·
,
South Korea
Class A
CE/IVDR
Automatic Chemiluminesence Immunoanalyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
Multi-functional MonitorⅠ
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
Compass2800-2
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
POCT Fully Immunofluorescence Quantitative Analyzer
Infitek Co., Ltd.
·
,
China
Class A
CE/IVDR
Fully Automatic Chemiluminescence analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Fluorescence Immunoassay Analyzer
Shenzhen Drawray Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Immunofluorescence Analyzer
Healgen Scientific Limited Liability Company
·
,
United States
Class A
CE/IVDR
BeneCheck Uni Premium Harnsäure-Messsystem
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Compass2000-2
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
FIAPro™ Mini Immunofluorescence Analyzer
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDR
CE/IVDD
Getein 1200 Immunofluorescence Quantitative Analyzer
Getein Biotech, Inc
·
,
China
Class A
CE/IVDR
Handheld DOA Reader
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
On Call Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Multi-function analyzer (blood glucose +3 more)
Hangzhou Lysun Biotechnology Co., Ltd
·
,
China
Class A
CE/IVDR
Compass2000-1
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Micro Heater Incubator
Vitrosens Biotechnology Inc.
·
,
Türkiye
Class A
CE/IVDR
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