5,168 results · 40ms · Sources: EU EUDAMED, US FDA

41371240

Certificate
MDD Annex II (excluding section 4)·X-Nav Technologies, LLC·INTERTEK SEMKO AB·4 Basic UDI-DIs

41371240-03

Certificate
MDD Annex II (excluding section 4)·X-Nav Technologies, LLC·INTERTEK SEMKO AB·12 Basic UDI-DIs

Hepatitis A virus (HAV)IgM Antibody Detection Kit (Magnetic Particle CLIA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Tianjin Bioscience Diagnostic Technology Co.,Ltd.·1 device

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·EZTRK 2, ACUITY SPIRAL, ORIGEN CRT-D, INOGEN CRT-D, DYNAGEN CRT-D, NAV 2 QUADPOLE, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, VI

PIXIUM DYNAMIC

Basic UDI-DI
EU MDR · Eu Md Class 2a ·THALES AVS FRANCE SAS·12 devices

Multi-layers decontamination antibacterial sticky mats

Basic UDI-DI
EU MDR · Eu Md Class 1 ·AV Medical CZ s.r.o.·42 devices

PIXIUM PORTABLE EZ HD

Basic UDI-DI
EU MDR · Eu Md Class 2a ·THALES AVS FRANCE SAS·2 devices

ArtPix Mobile EZ2GO

Basic UDI-DI
EU MDR · Eu Md Class 2b ·THALES AVS FRANCE SAS·1 device

CONVERTER

Basic UDI-DI
EU MDR · Eu Md Class 1 ·THALES AVS FRANCE SAS·2 devices

PROCESSING UNIT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·THALES AVS FRANCE SAS·6 devices

PIXIUM RAD 4343

Basic UDI-DI
EU MDR · Eu Md Class 2a ·THALES AVS FRANCE SAS·1 device

PIXIUM PORTABLE EZ / DR

Basic UDI-DI
EU MDR · Eu Md Class 2a ·THALES AVS FRANCE SAS·13 devices

GEM SRL

Manufacturer
🇮🇹 Italy·28 Basic UDI-DIs·38 Devices·TUV Rheinland Italia SRL, ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and TUV Rheinland Italia SRL

PTT

Basic UDI-DI
EU IVDD · Eu Ivd General ·NS BIOTEC·1 device

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·Fluency® Plus Endovascular Stent Graft

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·BARD FLAIR ENDOVASCULAR STENT GRAFT

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·Fluency™ Endovascular Stent Graft

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT