2,618 results
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37ms
·
Sources: EU EUDAMED, US FDA
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·CRCDx RAS Mutation Detection Assay Kit
Plasminogen, Antigen, Antiserum, Control
FDA classification
FDA Class 1
·Plasminogen, Antigen, Antiserum, Control
Radioimmunoassay, Total Thyroxine
FDA classification
FDA Class 2
·Radioimmunoassay, Total Thyroxine
Determine HIV Early Detect
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
EDTA Capillary Tubes
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Determine HIV Controls
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Chase Buffer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
FDA classification
FDA Class 2
·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
Abbott Rapid Dx International Limited
Importer
🇮🇪 Ireland·11 Manufacturers
Abbott Rapid Dx International Limited
Authorized representative
🇮🇪 Ireland·5 Manufacturers·4 Devices
Synthon auto-injector (brand names:MyJect, Autoxon, Perscleran, Sensigo)
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Synthon Hispania S.L.·2 devices
V7 103108 0005
Certificate
IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V7 103108 0007
Certificate
IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
AKRALAB S.L.U.
Importer
🇪🇸 Spain·8 Manufacturers
KTR Europe GmbH
Authorized representative
🇩🇪 Germany·135 Manufacturers·3461 Devices
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices