BEUDAMED
    FDA Registration Active 🇨🇳 China

    Jabil Circuit (Shanghai) Ltd.

    Reg #: 3005210579 · FEI: 3005210579 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    31

    Registration Details

    Registration Name
    Jabil Circuit (Shanghai) Ltd.
    Registration Number
    3005210579
    FEI Number
    3005210579
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    600 Tian Lin Road
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K163002

    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
    [email protected]
    Phone
    505 2030277

    Products

    Device Name Product Code
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification PGQ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Computer, Diagnostic, Programmable DQK
    Transducer, Ultrasonic, Diagnostic ITX
    Computer, Blood-Pressure DSK
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Thalamic, Epilepsy, Implanted MBX
    Deep Brain Stimulation For The Treatment Of Dystonia SGS
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence QPT
    Garment, Storage, Peritoneal Dialysis Catheter OAG
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Tubes, Gastrointestinal (And Accessories) KNT
    Powered Laser Surgical Instrument GEX
    Medical Device Data System OUG
    Counter, Sponge, Surgical LWH
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence QON
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Implant, Cochlear MCM
    Perineometer HIR
    Active Implantable Bone Conduction Hearing System PFO
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Implant, Auditory Brainstem MHE
    Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis PDZ
    Catheter, Percutaneous DQY
    Infusion Safety Management Software PHC
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    Nucleus® HybridTM Cochlear Implant System Recharger Kit Activa Altaviva Clinician Kit Altaviva System Recharger Belt Recharger Drape GentleLase Pro-U Communicator Patient Trial Belt InterStim MicroSystem Stryker F1 Charger Module Picoway Laser System Nucleus® 24 Cochlear Implant System Leva ® Pelvic Health System Leva Pelvic Digital Health System Leva Pelvic Health System Leva System Cochlear Osia 2 Sound Processor Kit LATITUDE Wave Communicator Model 6280 LATITUDE Wave Communicator Model 6290 Nucleus® Auditory Brainstem Implant GentleMax Pro C320LBB Delivery System Intelliport Reader; BD Osia System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device