BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    MicroPort CRM S.r.l.

    Reg #: 1000165971 · FEI: 1000165971 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    52
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    MicroPort CRM S.r.l.
    Registration Number
    1000165971
    FEI Number
    1000165971
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Crescentino s.n
    City
    Saluggia (VC) Vercelli
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K032466
    PMA Number
    P980049

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

    Proprietary Names

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

    Establishment Types

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