BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Esprit DR

    Reg #: 1000165971 · FEI: 1000165971 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MicroPort CRM S.r.l.
    Registration Number
    1000165971
    FEI Number
    1000165971
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Crescentino s.n
    City
    Saluggia (VC) Vercelli
    Country
    IT

    Regulatory Submissions

    PMA Number
    P950029

    Owner / Operator

    Firm Name
    MicroPort CRM S.R.L.
    Operator Number
    9059364
    Address
    5677 Airline Road, Regulatory Affairs, c/o Dwyndl Nelms
    City
    Arlington
    State
    TN
    Postal Code
    38002
    Country
    US
    Correspondent
    John - Skousen

    US Agent

    Business Name
    MicroPort CRM
    Contact Name
    John Skousen
    Address
    5677 AIRLINE ROAD, REGULATORY AFFAIRS, C/O DWYNDL NELMS
    City
    Arlington
    State
    TN
    ZIP
    38002
    Country
    US
    Email
    [email protected]
    Phone
    801 3864437

    Products

    Device Name Product Code
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Implantable Pacemaker Pulse-Generator DXY
    Pulse Generator, Permanent, Implantable NVZ

    Proprietary Names

    Esprit DR Accessory for pacemaker, ICD and CRT-D Permanent magnet Accessory for pacemaker, ICD and CRT-D Screw driver CPR3 telemetry wand (Accessory to SmartView Hotspot) SMARTVIEW Hotspot Brady Remote Monitoring System Reply SR Reply DR Esprit SR Smart Spot (Brady home monitor) CPR4BR telemetry wand (Accessory to Smart Spot) ALIZEA DR 1600 CELEA DR 1400 ALIZEA SR 1300 SmartView Connect App (V1) CELEA SR 1100

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device