BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Plexus Electronica S. de R.L. de C.V..

    Reg #: 3011120183 · FEI: 3011120183 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    64
    Establishment Types
    2
    Classifications
    36

    Registration Details

    Registration Name
    Plexus Electronica S. de R.L. de C.V..
    Registration Number
    3011120183
    FEI Number
    3011120183
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Paseo del Norte #4640, Guadalajara Technology Park
    City
    Zapopan Jalisco
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K121955

    Owner / Operator

    Firm Name
    PLEXUS CORP.
    Operator Number
    3019588
    Address
    ONE PLEXUS WAY, --
    City
    Neenah
    State
    WI
    Postal Code
    54956
    Country
    US

    Products

    Device Name Product Code
    Device, Positive Pressure Breathing, Intermittent NHJ
    Collector, Urine, Powered, Non Indwelling Catheter NZU
    Ventilator, Non-Continuous (Respirator) BZD
    Generator, Oxygen, Portable CAW
    Electrocautery, Gynecologic (And Accessories) HGI
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Instrument, Ultrasonic Surgical LFL
    Continuous, Ventilator, Home Use NOU
    Ventilator, Continuous, Facility Use CBK
    Standard Polysomnograph With Electroencephalograph OLV
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Laryngoscope, Rigid CCW
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Tape And Bandage, Adhesive KGX
    Detector And Alarm, Arrhythmia DSI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Pulse Generator, Permanent, Implantable NVZ
    Programmer, Pacemaker KRG
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Intra-Pulmonary Percussive Vibration (Ipv) Devices SDT
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Percussor, Powered-Electric BYI
    Ventilator, Continuous, Non-Life-Supporting MNS
    Device, Vein Location, Liquid Crystal KZA
    Ventilatory Effort Recorder MNR
    Sv70 Ventilator MNT
    Permanent Defibrillator Electrodes NVY
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Separator, Automated, Blood Cell, Diagnostic GKT
    Counter, Sponge, Surgical LWH
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Catheter, Coronary, Atherectomy MCX

    Proprietary Names

    COUGHASSIST T70 DEVICE PureWick Urine Collection System REMSTAR AUTO A-FLEX HT SIMPLYGO PORTABLE OXYGEN CONCENTRATOR The ETHICON™ Total Energy System Trilogy Evo REMSTAR SE Alice 6 LDx CNV, N.A. Alice 6 Conversion, LDx, Int'l A6,BS System, LDx, N.A.-RENTAL A6, BS System, LDx, N.A.-RECERT Alice 6, Base Station System, LDE, Int'l GlideScope® Spectrum Single Use System MCGRATH MAC Video Laryngoscope Dexcom G7 Continuous Glucose Monitoring System & Dexcom Overpatch CARESCAPE RAD REMSTAR AUTO A-FLEX TRILOGY 200 VENTILATOR RESPIRONICS SIMPLYCLEAR DEVICE HexaFlow™ Irrigation Pump - AFR-00005 Sphere S9 Catheter Extension Cable HexaGen™ RF Generator - AFR-00004 HexaPulse™ PF Generator - AFR-00008 DreamStation 2 System, DreamStation 2 Advanced System InCourage Device with Accessory Kit InCourage Device PTU S/A 120V, Yolk White, ICS-1M-US InCourage Device with Accessory Kit - VA BIPAP AVAPS VENTILATORY SUPPORT SYSTEM Dexcom G6 Pro Continuous Glucos Monitoring System Dexcom G7 Continous Glucose Monitoring System AV300 HF410 CL025 AccuVein Cover AccuVein HF510 Hands-free stand AV500 AV400 AccuVein HF550 Hands-free stand HF850 Hands-Free Powered Goose Neck Wheeled Stand HF470 HF450 Accuvein HF570 Hands-free stand TRILOGY 202 VENTILATOR BIPAP A 30 VENTILATORY SUPPORT SYSTEM TRILOGY 100 VENTILATOR ALICE PDX REMSTAR PRO WITH C-FLEX CPAP SYSTEM MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 L4 OXYGEN CONCENTRATOR BIPAP A 40 VENTILATORY SUPPORT SYSTEM GALAXY EMBLEM S-ICD Programmer PRO-FLOW MULTIPURPOSE CANNULA Rika Plasma Separation Set Dexcom G6 Continuous Glucose Monitoring System BIPAP AUTOSV ADVANCED Situate™ Delivery Console 200LD-V Sphere 360 Rika Plasma Donation System REMSTAR PLUS CPAP SYSTEM AngioJet Thrombectomy System - AutoElite Console Dexcom ONE+ Continuous Glucose Monitoring System Dexcom ONE Continuous Glucose Monitoring System REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)