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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
SmartTester
77 Elektronika Műszeripari Kft
·
,
Hungary
Class A
CE/IVDR
CERA-CHEK™ Hb Plus Hemoglobin Measuring System
GC MEDIS Corp.
·
,
South Korea
IVD for self-testing
CE/IVDD
Immunochromatography AI Reader
Shenzhen Everbest Machinery lndustry Co., Ltd.
·
,
China
Class A
CE/IVDR
STANDARD™ F200 Analyzer
SD Biosensor Inc.
·
,
South Korea
Class A
CE/IVDR
Immunofluorescence Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Hand-Held Immunofluorescence Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Multi-channel Immunofluorescence Analyzer
Healgen Life Science LLC
·
,
United States
Class A
CE/IVDR
Fluorescence immunoassay (FIA) Analyzer
Diasia Biomedical Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Plus Jet Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Bgi
Bgi Europe A/S
·
,
Denmark
Class A
CE/IVDR
Dry Fluorescence Immunoassay Analyzer
MaxBio (Tianjin) Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Liver Function Analysis Meter
Hangzhou Lysun Biotechnology Co., Ltd
·
,
China
Class A
CE/IVDD
CE/IVDR
Lactate Test Meter
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Supreme Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Curian Analyzer
Meridian Bioscience, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Magnetic Immunoassay System
Shenzhen BOSH Diagnostics, Ltd.
·
,
China
Class A
CE/IVDR
Microlife Multiplex Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Pathfast
Phc Corporation
·
,
Japan
Class A
CE/IVDR
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
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