FDA Registration
Active
🇨🇳 China
Jabil Circuit (Shanghai) Ltd.
Reg #: 3010972758
·
FEI: 3010972758
·
Expires 2026
Products
20
Proprietary Names
19
Establishment Types
1
Classifications
20
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Registration Details
- Registration Name
- Jabil Circuit (Shanghai) Ltd.
- Registration Number
- 3010972758
- FEI Number
- 3010972758
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6671 Jinhai Highway
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K140122
- PMA Number
- P910077
Owner / Operator
- Firm Name
- Jabil Inc.
- Operator Number
- 9074019
- Address
- 10800 Roosevelt Blvd.
- City
- Saint Petersburg
- State
- FL
- Postal Code
- 33716
- Country
- US
US Agent
- Business Name
- JABIL - NYPRO HEALTHCARE DIVISION
- Contact Name
- Lex Pearce
- Address
- 3801 University Blvd, SE
- City
- Albuquerque
- State
- NM
- ZIP
- 87106
- Country
- US
- [email protected]
- Phone
- 505 2030277
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2011-10-24 |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2019-06-12 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-06-12 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2021-02-10 |
| Stimulator, Electrical, Implantable, For Incontinence | EZW | Class 3 | Gastroenterology, Urology | No | 2020-08-07 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2017-11-20 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2017-11-20 |
| Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence | QPT | Class 3 | Unknown | No | 2025-09-19 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2015-09-03 |
| Infusion Safety Management Software | PHC | Class 2 | General Hospital | No | 2026-01-07 |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | QON | Class 3 | Gastroenterology, Urology | No | 2020-08-07 |
| Garment, Storage, Peritoneal Dialysis Catheter | OAG | Class 1 | Physical Medicine | No | 2020-07-13 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2020-06-30 |
| Stimulator, Thalamic, Epilepsy, Implanted | MBX | Class 3 | Unknown | No | 2020-06-30 |
| Deep Brain Stimulation For The Treatment Of Dystonia | SGS | Class 3 | Unknown | No | 2020-06-30 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2020-06-30 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2020-06-30 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-12-20 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2024-04-09 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2020-06-30 |
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
Recharger Belt
Recharger Drape
Activa
Recharger Kit
Communicator
Leva ® Pelvic Health System
Leva Pelvic Digital Health System
Leva Pelvic Health System
Leva System
GentleLase Pro-U
Establishment Types
Export Device to the United States But Perform No Other Operation on Device