BEUDAMED
    FDA Registration Active 🇫🇷 France

    Sorin CRM SAS

    Reg #: 3008159616 · FEI: 3008159616 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    54
    Establishment Types
    3
    Classifications
    11

    Registration Details

    Registration Name
    Sorin CRM SAS
    Registration Number
    3008159616
    FEI Number
    3008159616
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4, avenue Reaumur
    City
    CLAMART Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K042002
    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
    Computer, Diagnostic, Programmable DQK
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Pacemaker Pulse-Generator DXY
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Magnet, Test, Pacemaker DTG
    Defibrillator, Implantable, Dual-Chamber MRM
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN

    Proprietary Names

    Easyscope Synescope Synecom HRV Holter reader Synecom Accessory for pacemaker, ICD and CRT-D Permanent magnet Reply SR Reply DR CPR3 telemetry wand (Accessory to SmartView Hotspot) Esprit DR SMARTVIEW Hotspot Brady Remote Monitoring System Accessory for pacemaker, ICD and CRT-D Screw driver Esprit SR CPR4BR telemetry wand (Accessory to Smart Spot) Smart Spot (Brady home monitor) SmartView Connect App (V1) ALIZEA DR 1600 CELEA SR 1100 ALIZEA SR 1300 CELEA DR 1400 Holter cables Spiderview Spiderview plus Paradym RF CRT-D 9750 SMARTVIEW Home Monitor Intensia CRT-D 174 ORCHESTRA Plus Link PLATINIUM CRT-D 1711 PLATINIUM CRT-D 1741 PLATINIUM 4LV CRT-D 1744 Paradym CRT-D 8750 Smart Monitor (Home monitor) Magnet Paradym RF DR 9550 Paradym VR 8250 Intensia VR 124 Paradym DR 8550 Paradym RF VR 9250 PLATINIUM VR 1240 Intensia DR 154 PLATINIUM DR 1510 PLATINIUM DR 1540 PLATINIUM VR 1210 Orchestra Plus Programmer Smart Monitor CPR4 Remote Monitoring Software SmartTouch Programmer Software (SmartView) VEGA R52 Stylet Kit 52cm for VEGA R52 VEGA R45 Stylet Kit 58cm for VEGA R58 Stylet Kit 45cm for VEGA R45 VEGA R58

    Establishment Types

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