BEUDAMED
    FDA Registration Active 🇨🇳 China

    Leva ® Pelvic Health System

    Reg #: 3005210579 · FEI: 3005210579 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Jabil Circuit (Shanghai), Co. LTD.
    Registration Number
    3005210579
    FEI Number
    3005210579
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Tian Lin Road
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213913

    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
    Perineometer HIR

    Proprietary Names

    Leva ® Pelvic Health System Leva Pelvic Digital Health System Leva System Leva Pelvic Health System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)