BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Assert-IQ™ 3, Assert-IQ™ 3+, Assert-IQ™ EL+, Assert-IQ™ Insertion Tool, Assert-IQ™ Incision Tool

    Reg #: 3012552532 · FEI: 3012552532 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    St. Jude Medical Coordination Center BVBA European Distribution Center
    Registration Number
    3012552532
    FEI Number
    3012552532
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BruCargo 831
    City
    BruCargo Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K230286

    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
    Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) MXC
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    Assert-IQ™ 3, Assert-IQ™ 3+, Assert-IQ™ EL+, Assert-IQ™ Insertion Tool, Assert-IQ™ Incision Tool

    Establishment Types

    Repack or Relabel Medical Device