48 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
×
Automatic Chemiluminescence Immunoassay Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·Hotgen (Langfang) Biotech Co., Ltd.·On the market·2 countries
Progesterone (CLIA)
Device
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Progesterone (CLIA)
Device
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
Immunofluorescence Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen Superbio Technology Co.,Ltd.·On the market
VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·Beijing Tigsun Diagnostics Co., Ltd.·On the market·32 countries
cobas pure integrated solutions Language Pack – English Version 1.3.en
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
IDS ACTH N Calibrator Set
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·32 countries
RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
Device
EU IVDR
·
Eu Ivd Class C
·Zybio Inc.·On the market·32 countries
CELL COUNTING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·UIMD Inc.·On the market
PurePrep Path DX Kit (480 rxn)
Device
EU IVDR
·
Eu Ivd Class A
·IST Innuscreen GmbH·On the market
LUCIA Cytogenetics
Device
EU IVDR
·
Eu Ivd Class C
·Laboratory Imaging s.r.o.·On the market·12 countries
cobas pure integrated solutions System Software Version 01-03
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA
Device
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·On the market·32 countries
Kit Água
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Plasticerveira - Transformação de Plástico, Lda·1 device
VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
Progesterone (CLIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices
Automatic Chemiluminescence Immunoassay Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hotgen (Langfang) Biotech Co., Ltd.·1 device
Wash Solution
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Genrui Biotech Inc.·1 device
Sample Diluent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Genrui Biotech Inc.·1 device
Quantitative lmmunoassay Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Genrui Biotech Inc.·1 device