BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    St. Jude Medical Coordination Center BVBA European Distribution Center

    Reg #: 3012552532 · FEI: 3012552532 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    60
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    St. Jude Medical Coordination Center BVBA European Distribution Center
    Registration Number
    3012552532
    FEI Number
    3012552532
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BruCargo 831
    City
    BruCargo Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K201148
    PMA Number
    P110016

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Tourniquet, Nonpneumatic GAX
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Cardiac Ablation Percutaneous Catheter LPB
    Computer, Diagnostic, Programmable DQK
    Implantable Pacemaker Pulse-Generator DXY
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pulse Generator, Permanent, Implantable NVZ
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) MXC
    Detector And Alarm, Arrhythmia DSI
    Stylet, Catheter DRB

    Proprietary Names

    RadiStop Ampere Generator FlexAbility Ablation Catheter Sensor Enabled™ Ablation Connection Cable Therapy Cool Flex Ablation Catheter FlexAbility Ablation Catheter, Sensor Enabled Therapy Cool Path Duo Ablation Catheter Safire BLU Duo Ablation Catheter IBI 1500T9-CP V1.6 Cardiac Ablation Generator Ampere™ Generator Accessories Ampere™ Generator Fiber Cord Assembly Remote Ampere™ Generator Kit Ampere™ Remote Control Ampere™ Footswitch EnSite™ LiveView Dynamic Display Software License EnSite Precision™ Software Installation v2.6 EnSite Precision™ Software Upgrade v2.7.1 EnSite Precision™ Software Installation v.2.7 H702701 EnSite Precision Surface Electrode Kit EN0020-p EnSite Precision™ System Software Upgrade v.2.6.1, H702602 Current DR, VR ICD, Merlin Antenna, Promote ICD Vein Pick Neutrino NxT Models - CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA800T, CDVRA600T, CDDRA800T, CDDRA600T Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR Merlin Patient Care System Software Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Merlin.net Patient Care Network s/w Silicone Oil DF-1 Receptacle Plug, Hex Wrench, Merlin Patient Care System Software Model 3330 Version 18.1.1 Entrant Models - CDDRA300Q, CDVRA300T, CDDRA300T Merlin Live Connect Software Model MLC1000 Avant Models - CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T Gallant Models - CDVRA500Q, CDDRA500Q, CDVRA500T, CDDRA500T Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR Stylet Kit, Promote ICD Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD IS-1 Receptacle Plus, Medical Adhesive Merlin@home Transmitter software, Durata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4 Quadra Assura CRT-D, Unify Assura CRT-D Promote CRT-Ds, Stylet Kit, Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick Current DR, VR ICDs, Promote ICDs, Merlin Antenna QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve, CRT Leads, Quickflex Left Heart Leads Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System TactiSys Quartz Equipment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ Assert-IQ™ 3, 3+, EL, Insertion and Incision Tools - Models DM5000, DM5300, DM5500, DM5310, DM5510, DM5320 Stylet Models 4060, 4062, 4064. 4090, 4091, 4078

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device