Jabil Circuit (Shanghai) Ltd.
Registered establishment in Shanghai, China. 31 device types.
Jabil Circuit (Shanghai) Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Perineometer, Implant, Cochlear and 29 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010972758 |
| FEI number | 3010972758 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 捷普科技（上海）有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 6671 Jinhai Highway |
| Postal code | 200000 |
| Country | China |
What It Makes
Clearances
No clearance names Jabil Circuit (Shanghai) Ltd. as applicant. 9 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243062 | 2025-06-20 | PHC | Traditional | Becton, Dickinson & Co. |
| K220853 | 2022-10-13 | GEX | Traditional | Candela Corporation |
| K213913 | 2022-06-30 | HIR | Traditional | Renovia, Inc. |
| K201111 | 2020-05-26 | GEX | Special | Candela Corporation |
| K163002 | 2017-05-16 | KNT | Traditional | Covidien (Dba Medtronic) |
| K150728 | 2015-08-14 | ERL | Traditional | Medtronic Xomed, Inc. |
| K140732 | 2014-11-07 | GEX | Special | Candela Corporation |
| K140122 | 2014-05-09 | GEX | Traditional | Candela Corporation |
| K033172 | 2003-10-30 | GEX | Traditional | Candela Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Factory area | 155,000 sq ft |
| Main products | Medical device manufacturing, Electronics manufacturing services |
| Certifications | ISO 9000, TS 16949, AS 9100, ISO 13485, ISO 17025 |
| Export markets | Multiple (global EMS provider) |
| OEM and ODM | Offered |
PMA Approvals
A premarket approval is the Class III route: granted on clinical evidence, not on equivalence to a device already on the market.
| PMA number | Decision | Trade name | Product code | Held by |
|---|---|---|---|---|
| P240011 | 2025-10-17 | Altaviva Implantable Neurostimulator | QPT | Medtronic Neuromodulation |
| P840001 | 2025-10-16 | Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and | LGW | Medtronic Neuromodulation |
| P970004 | 2025-09-05 | InterStim® Therapy System; Verify® Evaluation System | EZW | Medtronic Neuromodulation |
| P080025 | 2024-12-13 | InterStim Therapy System, Verify Evaluation System | QON | Medtronic Neuromodulation |
| P960009 | 2024-06-27 | Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense | MHY | Medtronic, Inc. |
| P030017 | 2023-01-06 | Precision Spinal Cord Stimulator (SCS) Systems | LGW | Boston Scientific Corporation |
| P910077 | 2007-12-05 | VENTAK MINI & CONTAK RENEWAL 3 | LWS | Boston Scientific Corporation |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.