Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010972758

FEI Number

3010972758

Entity Name

Jabil Circuit (Shanghai) Ltd.

City/State/Country

Shanghai, CN

Establishment Address

6671 Jinhai Highway, Shanghai 200000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Jabil Inc. (Owner Number: 9074019)

Owner / Operator Contact Address

10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P080025

All Registered Proprietary Names

LATITUDE Wave Communicator Model 6280 LATITUDE Wave Communicator Model 6290 GentleMax Pro Patient Trial Belt Picoway Laser System InterStim MicroSystem Altaviva Clinician Kit Altaviva System Intelliport Reader; BD InterStim MicroSystem

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2011-10-24
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2019-06-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-06-12
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2021-02-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-05
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	Class 3	876.5270	2020-08-07
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-11-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-11-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-03-10
QPT	Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence	Unknown	Class 3	N/A	2025-09-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-07-02
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2015-09-03
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2026-01-07
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	Gastroenterology, Urology	Class 3	876.5270	2020-08-07

Official Correspondent

No official correspondent registered.

US Agent Details

Lex Pearce Business: JABIL - NYPRO HEALTHCARE DIVISION Email: lex_pearce@jabil.com Phone: (505) 2030277

Related Public Records

Same Entity

Jabil Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3011246727	Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3003512059	NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, DO
3004730544	NYPRO DR, LLC (Building 52)	Haina San Cristobal, DO
1424235	Nypro Inc. (Chicago)	GURNEE, IL, 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-0033-2018	St Jude Medical Inc.	3	Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-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-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667

Similar Registrations

Registration Number	Establishment Name	Location
9614453	Medtronic Europe Sarl	TOLOCHENAZ Vaud, CH
2649622	MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA	Villalba, PR, US
1028232	BIOTRONIK, INC.	LAKE OSWEGO, OR, US
2183787	Greatbatch Medical	Minneapolis, MN, US
3015453963	CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI	Maltepe Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010972758. Last updated year: 2026. Please use registration number 3010972758 when referencing this establishment in official correspondence.