Plexus Manufacturing Sdn .Bhd.

FDA Device Registration & Listing · Bayan Lepas Pulau Pinang, MY · Registration 3006786907

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
3006786907
FEI Number
3006786907
Entity Name
Plexus Manufacturing Sdn .Bhd.
City/State/Country
Bayan Lepas Pulau Pinang, MY
Establishment Address
Plot 87, 88 & 89 Lebuhraya Kampung Jawa,, 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

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) ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System PENTAX Medical Video Processor (EPK-i8020c) 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-07-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-07-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-07-21
MKQ Processor, Cervical Cytology Slide, Automated Unknown Class 3 N/A 2024-01-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-05-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-05-03
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2023-06-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-05-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-05-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-05-20
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2019-09-20
FOX Stand, Infusion General Hospital Class 1 880.6990 2023-05-08
JQX Nephelometer, For Clinical Use Clinical Chemistry Class 1 862.2700 2024-10-13
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-12-26
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement Gastroenterology, Urology Class 2 876.1500 2025-06-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-11-28
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement Gastroenterology, Urology Class 2 876.1500 2023-02-02
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement Gastroenterology, Urology Class 2 876.1500 2023-08-20
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2022-11-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-07-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-07-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-07-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-02-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-02-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-02-03
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement Gastroenterology, Urology Class 2 876.1500 2021-06-09
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement Gastroenterology, Urology Class 2 876.1500 2018-01-10
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2025-12-01

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
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006786907. Last updated year: 2026. Please use registration number 3006786907 when referencing this establishment in official correspondence.
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