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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
Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class A
CE/IVDR
Mini Immunofluorescence Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Fluorescence Immunoassay Analyzer
Xiamen Boson Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Immunofluorescence Analyzer
Healgen Scientific Limited Liability Company
·
,
United States
Class A
CE/IVDR
i-ImmunDx Analyzer
Seinda Biomedical Corporation
·
,
China
IVD General
CE/IVDD
On Call GU Dual Blood Glucose and Uric Acid Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Lipid Testing System
Hangzhou Bosure Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class A
CE/IVDR
IFFD001E
Sugentech, Inc.
·
,
South Korea
Class A
CE/IVDR
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