FDA Registration
Active
🇲🇾 Malaysia
Plexus Manufacturing Sdn. Bhd.
Reg #: 3004593495
·
FEI: 3004593495
·
Expires 2026
Products
30
Proprietary Names
30
Establishment Types
1
Classifications
30
Registration Details
- Registration Name
- Plexus Manufacturing Sdn. Bhd.
- Registration Number
- 3004593495
- FEI Number
- 3004593495
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bayan Lepas Free Industrial Zone, Phase II
- City
- Bayan Lepas Pulau Pinang
- Country
- MY
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 Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2019-09-06 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2019-09-06 |
| Pulse-Generator, Pacemaker, External | DTE | Class 2 | Cardiovascular | No | 2018-09-25 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2015-06-03 |
| External Cerebrospinal Fluid (Csf) Diversion | PCB | Class 2 | Neurology | No | 2022-01-11 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2025-08-14 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2019-02-21 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2019-09-27 |
| Stimulator, Thalamic, Epilepsy, Implanted | MBX | Class 3 | Unknown | No | 2019-09-27 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2019-09-27 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2019-09-27 |
| Ablation Catheter, Renal Denervation | QYI | Class 3 | Unknown | No | 2023-11-19 |
| Implanted Subcortical Electrical Stimulator (Motor Disorders) | MRU | Class f | Unknown | No | 2021-05-04 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2023-12-15 |
| Stimulator, Electrical, Implantable, For Incontinence | EZW | Class 3 | Gastroenterology, Urology | No | 2014-08-14 |
| Catheter, Ventricular | HCA | Class 2 | Neurology | No | 2022-01-11 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2025-06-11 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2021-06-10 |
| Pump, Infusion, Implanted, Programmable | LKK | Class 3 | Unknown | No | 2019-09-27 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2013-06-25 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2018-09-02 |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | QON | Class 3 | Gastroenterology, Urology | No | 2014-08-15 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2008-07-22 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2008-07-22 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2008-07-22 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2007-10-18 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2017-07-25 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2017-07-25 |
| Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) | OLM | Class f | Unknown | No | 2021-05-04 |
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2021-04-27 |
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
DiamondTemp Generator Connection Box E
Multi Lead Trial Cable
AutoLog IQ Autotransfusion System
Merlin@Home
MyCareLink Smart Monitor
MyCareLink Patient Monitor
CareLink SmartSync Base 24970A
CareLink SmartSync Patient Connector 24967
Intellis
Model 97755 Recharger
Model 97725 Wireless External Neurostimulator
Model 8880T2 Communicator
Model 97745 Controller
Puffin
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)