2,530 results
·
45ms
·
Sources: EU EUDAMED, US FDA
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT ENDOPROSTHESIS VENOUS
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK Automated External Defibrillators
Pulse Generator, External Pacemaker, Dual Chamber
FDA Pre-Market Approval
FDA Class 2
·RELIATY / MODEL 3145 PACING SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·QUIK-COMBO® Therapy Cable
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·QUIK-COMBO® Therapy Cable (a necessary AED accessory of the LIFEPAK® 15 Monitor/Defibrillator)
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·samaritan Public Access Automated External Defibrillators and Accessories
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK® 15 monitor/defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Avive Automated External Defibrillator (AED) System
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·AED 3 Defibrillator with Uni-Padz
SCENAR CENTER - BULGARIA ltd
Authorized representative
🇧🇬 Bulgaria·1 Manufacturer
Antistreptolysin “O”
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·10 devices
OKO SOLUTION
Authorized representative
🇫🇷 France·2 Manufacturers·44 Devices
FI13/07001
Certificate
MDD Annex II (excluding section 4)·Optomed Oyj·SGS FIMKO OY·6 Basic UDI-DIs
FI24/00000061
Certificate
MDR QMS·Optomed Oyj·SGS FIMKO OY
FI120/07001P0
Certificate
MDD Annex II (excluding section 4)·Optomed Oyj·SGS FIMKO OY·1 Basic UDI-DI