Plexus Manufacturing Sdn. Bhd.

FDA Device Registration & Listing · Bayan Lepas Pulau Pinang, MY · Registration 3004593495

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004593495
FEI Number
3004593495
Entity Name
Plexus Manufacturing Sdn. Bhd.
City/State/Country
Bayan Lepas Pulau Pinang, MY
Establishment Address
Bayan Lepas Free Industrial Zone, Phase II, Bayan Lepas Pulau Pinang 11900, MY
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Medtronic Becker External Drainage and Monitoring System (Becker EDMS) External Pulse Generator Patient Assistant DUET External Drainage and Monitoring System Medtronic Model 5392 External Pulse Generator (EPG) Medtronic Temporary External Pacemaker Liberant Blood Conservation unit (BCU) External Motor Emergency Hand Crank Communicator Symplicity Spyral™ Renal Denervation System 8880T2 Communicator PulseSelect™ Pulsed Field Ablation (PFA) Verify Evaluation System Medtronic Exacta External Drainage and Monitoring System (Exacta EDMS) VitalFlow Console Patient Assistant Medtronic Model 5392 External Pulse Generator (EPG) DiamondTemp Generator Connection Box E Communicator Multi Lead Trial Cable AutoLog IQ Autotransfusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2019-09-06
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-09-06
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2018-09-25
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2015-06-03
PCB External Cerebrospinal Fluid (Csf) Diversion Neurology Class 2 882.5560 2022-01-11
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2023-10-19
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2018-09-13
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-14
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2019-02-21
NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Unknown Class 3 N/A 2019-09-27
MBX Stimulator, Thalamic, Epilepsy, Implanted Unknown Class 3 N/A 2019-09-27
PJS Stimulator, Electrical, Implanted, For Essential Tremor Unknown Class 3 N/A 2019-09-27
MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor Unknown Class 3 N/A 2019-09-27
QYI Ablation Catheter, Renal Denervation Unknown Class 3 N/A 2023-11-19
MRU Implanted Subcortical Electrical Stimulator (Motor Disorders) Unknown Class f N/A 2021-05-04
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2023-12-15
EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology Class 3 876.5270 2014-08-14
HCA Catheter, Ventricular Neurology Class 2 882.4100 2022-01-11
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2022-01-11
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular Class 2 870.4100 2025-06-11
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2020-04-14
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2016-12-12
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2021-06-10
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2019-09-27
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2013-06-25
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2018-09-02

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
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K891148 Del Mar Avionics MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM 1989-05-11
K914092 Nihon Kohden America, Inc. BSM-2100A CONFIGURED PATIENT MONITOR 1992-05-28
K153473 Braemar Manufacturing, LLC Braemar Telemetry Patch System 2016-07-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2025 Philips North America 2
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05 General Electric Medical Systems Information Technology 2
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011 Philips Medical Systems North America Co. Phillips 2
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025 Philips North America 2
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Z-0023-2018 St. Jude Medical, Inc. 3
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004593495. Last updated year: 2026. Please use registration number 3004593495 when referencing this establishment in official correspondence.
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