1,369 results
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39ms
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Sources: EU EUDAMED, US FDA
170726773
Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·8 Basic UDI-DIs
059786 MR2 170726773
Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·IFORIA 5/7 DR-T/VR-T/VR-T DX; INVENTRA 7 DR-T/VR-T/VR-T DX; IPERIA 5/7 DR-T/VR-T/VR-T DX; LUMAX 300/340 DR/DR-T/VR/VR-T
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·BIOMERIEUX THXID BRAF ASSAY KIT
hybcell Bacteria DNA xB
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
hybcell Fungi DNA xB
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
hybcell Pathogens DNA xB
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box Bacteria
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box Fungi
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box Resistance
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
LINA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
IPC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
GINA 500
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
GINA 500 + DNA purification
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box IPC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
hyborg Dx RED2
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Cube Dx GmbH·5 devices
Hydropump
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DX Products Limited·45 devices
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARELINK MONITORS, CARELINK EXPRESS MONITIORS, CARDIOSIGHT READERS, REVEAL DX, REVEAL XT
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)