FDA Registration
Active
🇲🇾 Malaysia
Plexus Manufacturing Sdn .Bhd.
Reg #: 3006786907
·
FEI: 3006786907
·
Expires 2026
Products
16
Proprietary Names
30
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- Plexus Manufacturing Sdn .Bhd.
- Registration Number
- 3006786907
- FEI Number
- 3006786907
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot 87, 88 & 89 Lebuhraya Kampung Jawa,
- 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 |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-01-22 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-07-21 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-07-21 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-07-21 |
| Processor, Cervical Cytology Slide, Automated | MKQ | Class 3 | Unknown | No | 2024-01-05 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2023-06-21 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2019-09-20 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2023-05-08 |
| Nephelometer, For Clinical Use | JQX | Class 1 | Clinical Chemistry | No | 2024-10-13 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-12-26 |
| Endoscope, Accessories, Image Post-Processing For Color Enhancement | PEA | Class 2 | Gastroenterology, Urology | No | 2025-06-10 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2022-11-25 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2025-12-01 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2020-03-13 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2024-08-23 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-02-05 |
Proprietary Names
Vbeam Prima Pro
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
BD PrepMate
ACUSON Maple Select Diagnostic Ultrasound System
ACUSON Maple Diagnostic Ultrasound System
INSTACLEAR CONSOLE
Aixplorer®& Aixplorer® Ultimate
GlideScope® Spectrum Single Use System
MCGRATH MAC Video Laryngoscope
Novum IQ Hub Docking Station
BD Phoenix AP
EnCor EnCompassTM Breast Biopsy and Tissue Removal System
PENTAX Medical Video Processor (EPK-i8020c)
PENTAX Medical Keyboard EN (OS-A115)
EZ2 Connect MDx
ACUSON P500 Ultrasound System
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
Reusable Water Bottle (OS-H5)
Pentax Medical EPK-i7010 Video Processor with GI Family
EPK-i7010 GI
PENTAX Medical EPK-i7010 Video Processor for Gastrointestinal Indications for Use
PENTAX Medical Keyboard (OS-A83)
Glace
eReader+ Drug Screening Instrument
PENTAX Medical Video Processor EPK-i5500c
PENTAX Medical keyboard EN (OS-A116)
PENTAX Medical keyboard EN (OS-A111)
ACUSON Redwood Diagnostic Ultrasound System
PENTAX Medical Video Processor EPK-3000
PENTAX Medical Keyboard EN (OS-A94)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)