FDA Registration Active 🇨🇭 Switzerland

Medtronic Europe Sarl

Reg #: 9614453 · FEI: 3002807576 · Expires 2026
Products
14
Proprietary Names
170
Establishment Types
2
Classifications
14

Registration Details

Registration Name
Medtronic Europe Sarl
Registration Number
9614453
FEI Number
3002807576
Status
Active
Expiry Year
2026
Initial Importer
No
Address
ROUTE DU MOLLIAU 31, Case Postale
City
TOLOCHENAZ Vaud
Country
CH

Regulatory Submissions

510(k) Number
K212008
PMA Number
P010031

Owner / Operator

Firm Name
Medtronic, Inc.
Operator Number
2112641
Address
710 Medtronic Parkway
City
Minneapolis
State
MN
Postal Code
55432
Country
US

Products

Device Name Product Code
Pulse Generator, Permanent, Implantable NVZ
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
Programmer, Pacemaker KRG
Implantable Cardioverter Defibrillator (Non-Crt) LWS
Pacemaker/Icd/Crt Non-Implanted Components OSR
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
Leadless Pacemaker PNJ
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) MXD
Detector And Alarm, Arrhythmia DSI
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
Implantable Pacemaker Pulse-Generator DXY
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
Permanent Defibrillator Electrodes NVY

Proprietary Names

Viva Quad S CRT-D Claria MRI Quad CRT-D Amplia MRI CRT-D SureScan Concerto II CRT-D Viva S CRT-D Consulta ICD Brava Viva Maximo II CRT-D Protecta XT CRT-D Brava Quadripolar CRT-D Viva Quad XT CRT-D Protecta CRT-D Consulta DF4 ICD Compia MRI Quad CRT-D SureScan Compia MRI CRT-D SureScan Viva XT CRT-D Amplia MRI Quad CRT-D SureScan Concerto ICD Claria MRI CRT-D Crome HF CRT-D MRI SureScan Crome HF Quad CRT-D MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan Cobalt XT HF CRT-D MRI SureScan Cobalt HF CRT-D MRI SureScan Micra Transcatheter Pacemaker System Micra TPS Micra AV TPS Micra AV2 TPS Micra VR2 TPS Transvene Lead Reveal LINQ Patient Assistant REVEAL LINQ Advisa DR MRI SureScan Advisa DR Adapta InCheck Patient Assistant Relia IPG Adapta L Adapta S Advisa SR MRI SureScan Versa DR IPG Sensia DR IPG Azure XT DR MRI Azure S SR MRI Azure XT SR MRI Azure S DR MRI CareLink SmartSync Azure Astra Application Sphera DR MRI Attesta L DR MRI Attesta SR MRI Attesta S DR MRI Attesta DR MRI Sphera SR MRI Sphera L DR MRI Sensia IPG Analyzer Adapter Prodigy IPG Medtronic CareLink Monitor Service Kit Adapter Cable Sterile Plastic Sleeve CapSure Lead CareLink Express Mobile System - Android CapSure VDD-2 Lead CareLink Express Monitor ECG Port Plug ECG Output Adapter CareLink Wireless Network Adapter Card Program Interface Cable CareLink Express Mobile System - iOS CareLink Encore Programmer Analyzer Cable ECG Cable Lead Analyzer MyCareLink Patient Monitor CardioSight Reader CareLink Encore Programmer RF Head CareLink Programmer RF Head Medtronic CareLink Programmer CareLink SmartSync Power Cord 249705 CareLink SmartSync Patient Connector 24967 CareLink SmartSync Base 24970A CareLink SmartSync PSA Application CareLink SmartSync Common Application iOS CareLink SmartSync Power Supply 249701 Integrated Diagnostics Data Calculation Module Model 5242 Instrument Command Library (ICL)Device Command Library (DCL) Reveal DX Reveal XT Reveal LINQ™ Insertion Tools CapSureFix MRI SureScan Lead Revo MRI SureScan Syncra CRT-P Attain Viva CRT-P Solara CRT-P MRI SureScan Percepta CRT-P MRI SureScan Solara Quad CRT-P MRI SureScan Insync Attain Bipolar OTW Lead Consulta CRT-P Percepta Quad CRT-P MRI SureScan Attain OTW Serena CRT-P MRI SureScan Serena Quad CRT-P MRI SureScan CareLink SmartSync Percepta, Solera, Serena Application PCD End Cap GEM Patient Cable Lead Patch MICRO JEWEL Patient Magnet MICRO JEWEL II Ace Header Emulator Epicardial Patch Lead Upsizing Sleeve Sizing Sleeve GEM VR CareLink Network Software Protecta VR Marquis VR ICD Visia AF MRI VR SureScan Evera XT VR Protecta DR Visia AF MRI S VR SureScan Virtuoso II DR/VR ICD Maximo II DR Visia AF VR Evera MRI S VR Evera XT DR Evera MRI XT DR SureScan Maximo VR ICD Evera S DR Evera MRI S DR SureScan Marquis DR ICD Evera S VR Secura DR Protecta XT VR Protecta XT DR Intrinsic ICD Evera MRI XT VR SureScan EnTrust ICD Secura VR Evera Medtronic Longevity Maximo II VR Maximo DR ICD Primo MRI VR SureScan Primo MRI DR SureScan Cobalt XT DR MRI Surescan Cobalt VR MRI Surescan Cobalt DR MRI Surescan Crome DR MRI Surescan Crome VR MRI Surescan Cobalt XT VR MRI Surescan Vitatron C20 SR IPG CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025 Epsila EV™ MRI SureScan™ extravascular lead Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator Epsila EV™ Sternal Tunneling Tool AURORA EV-ICD™ MRI SURESCAN™ SW041 Epsila EV™ Transverse Tunneling Tool Reveal XT Patient Assistant Reveal XT ICM Reveal Patient Assistant Reveal DX ICM

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device