3,874 results
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40ms
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Sources: EU EUDAMED, US FDA
Mission HDL High Density Lipoprotein Test Devices
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·Acon Biotech (Hangzhou) Co., Ltd.·1 device
QUIK-CHECK HDL High Density Lipoprotein Test Devices
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Acon Biotech (Hangzhou) Co., Ltd.·1 device
HDL UNION SRL
Importer
🇷🇴 Romania·4 Manufacturers
High Density Lipoprotein Cholesterol (HDL-C) Kit (Enzymatic Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Blood Lipid Reagent Kit (TC/TG/HDL-C/LDL-C)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Changsha Sinocare Inc.·1 device
Thyroglobulin, Rhodamine, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Thyroglobulin, Rhodamine, Antigen, Antiserum, Control
Berthelot Indophenol, Urea Nitrogen
FDA classification
FDA Class 2
·Berthelot Indophenol, Urea Nitrogen
Safeguard Technologies Limited
Importer
🇮🇪 Ireland·3 Manufacturers
High-Density Lipoprotein Cholesterol (HDL-C) Assay Kit (Direct Method - Selective Inhibition Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
FDA classification
FDA Class 1
·Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
CE 663351
Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE663351
Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI
ADL FARMACEUTICI SRL
System producer
🇮🇹 Italy
Lipoprotein, High Density, Hdl, Over The Counter
FDA classification
FDA Class 1
·Lipoprotein, High Density, Hdl, Over The Counter
Eastimpex DL Kft.
Importer
🇭🇺 Hungary
LDL
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·NS BIOTEC·1 device
D + L Dubois + Linke GmbH
Importer
🇩🇪 Germany
Anterior Spine Fixation System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Chongqing FWS Medical Device Co.,Ltd·1 device
Anterior Spine Fixation System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Chongqing FWS Medical Device Co.,Ltd·1 device