Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011120183

FEI Number

3011120183

Entity Name

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

City/State/Country

Zapopan Jalisco, MX

Establishment Address

Paseo del Norte #4640, Guadalajara Technology Park, Zapopan Jalisco 45010, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PLEXUS CORP. (Owner Number: 3019588)

Owner / Operator Contact Address

ONE PLEXUS WAY, --, Neenah, WI 54956, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 REMSTAR AUTO A-FLEX HT 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 CARESCAPE RAD CARESCAPE RAD 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2024-05-24
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2019-08-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-05-24
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2024-05-16
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2025-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-26
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2025-02-26
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2024-05-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-05-24
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-07-24
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2024-05-24
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2024-05-24
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2019-09-20
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-12-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-11
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-05-06
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-05-06
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-05-16
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2008-11-25
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2008-11-25
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2008-11-25
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2008-11-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-05-16
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-05-24
SDT	Intra-Pulmonary Percussive Vibration (Ipv) Devices	Anesthesiology	Class 2	868.5665	2024-05-24
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2025-06-30
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2025-06-30
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2025-06-30
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2024-05-16
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-05-16
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2024-05-24
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2024-05-16
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-12-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-05-06
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-05-06
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-05-06
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-05-06
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2023-09-07
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2007-11-14
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-05-24
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2024-05-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-05-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-05-24
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-05-16
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2024-05-16
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2024-05-16
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2024-05-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-05-16
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2013-09-09
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2013-09-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-05-29
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2022-06-21

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Theune Email: Scott.Theune@plexus.com Phone: (920) 7513571

Related Public Records

Same Entity

PLEXUS CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011606051	PLEXUS SERVICES RO SRL	Oradea Bihor, RO
3034431159	Plexus (Thailand) Co., Ltd.	Amphur Bang Pakong Chachoengsao, TH
3008754394	Plexus Corp. (UK) Limited	Kelso Scottish Borders, The, GB
3006063136	Plexus (Xiamen) Co. Ltd.,	Xiamen, Fujian, CN
2183715	PLEXUS CORP.	Neenah, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

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3023272766	CEVA LOGISTICS LIMITED	Daventry Northamptonshire, GB
2183816	HILL-ROM MANUFACTURING, INC.	SAINT PAUL, MN, US
3008145987	Hill-Rom Services Private Limited	Singapore North East, SG
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011120183. Last updated year: 2026. Please use registration number 3011120183 when referencing this establishment in official correspondence.