5,542 results
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42ms
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Sources: EU EUDAMED, US FDA
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis
Kai Europe GmbH
Importer
🇩🇪 Germany·1 Manufacturer
K.A. Pythevs Ltd
Importer
🇨🇾 Cyprus
KAB Import GmbH
Importer
🇦🇹 Austria
LCD Monitor
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Qingdao Hisense Medical Equipment Co., Ltd·3 devices
LCD Monitor
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Qingdao Hisense Medical Equipment Co., Ltd·8 devices
LCD Monitor
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Qingdao Hisense Medical Equipment Co., Ltd·4 devices
Ultrasound Diagnostic System
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Qingdao Hisense Medical Equipment Co., Ltd·52 devices
381008
Certificate
MDD Annex V·KAZ Europe Sàrl·DQS Medizinprodukte GmbH·2 Basic UDI-DIs
200234 QS/NB
Certificate
MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·4 Basic UDI-DIs
200234QS/NB
Certificate
MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Iliac Branch Endoprosthesis
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·H&LB ONE-SHOT DELIVERY SYSTEM FOR USE WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT
Serum Amyloid A (SAA) Kit (Latex Particle-Enhanced Immunonephelometry Method)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices
Kai Europe GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·6 Devices
HZ 2066395-1
Certificate
MDR QMS·Kai Industries Co., Ltd.·TÜV Rheinland LGA Products GmbH
Hemodialyzer With Expanded Solute Removal Profile
FDA classification
FDA Class 2
·Hemodialyzer With Expanded Solute Removal Profile