BEUDAMED
    FDA Registration Active 🇫🇷 France

    Esprit SR

    Reg #: 3008159616 · FEI: 3008159616 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Sorin CRM SAS
    Registration Number
    3008159616
    FEI Number
    3008159616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4, avenue Reaumur
    City
    CLAMART Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    PMA Number
    P950029

    Owner / Operator

    Firm Name
    MicroPort CRM USA, Inc.
    Operator Number
    2182863
    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 USA, INC.
    Contact Name
    John Skousen
    Address
    5677 Airline Road, Regulatory Affairs, c/o John Skuosen (MicroPort CRM)
    City
    Arlington
    State
    TN
    ZIP
    38002
    Country
    US
    Email
    [email protected]
    Phone
    801 3864437

    Products

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

    Proprietary Names

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198