BEUDAMED
    FDA Registration Active 🇫🇷 France

    GAMBRO INDUSTRIES

    Reg #: 8010182 · FEI: 3002807204 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    GAMBRO INDUSTRIES
    Registration Number
    8010182
    FEI Number
    3002807204
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7, AV. LIONEL TERRAY, B.P. 126
    City
    MEYZIEU CEDEX Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K042938
    PMA Number
    P830063

    Owner / Operator

    Firm Name
    Vantive US Healthcare LLC
    Operator Number
    9038727
    Address
    510 Lake Cook Road
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Jennifer Masek-Little

    US Agent

    Business Name
    Vantive US Healthcare LLC
    Contact Name
    Jennifer Masek-Little
    Address
    510 Lake Cook Rd
    City
    Deerfield
    State
    IL
    ZIP
    60015
    Country
    US
    Email
    [email protected]
    Phone
    815 3548549

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Subsystem, Water Purification FIP
    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma MDP

    Proprietary Names

    PRISMAFLEX HF 1000 SET PRISMAFLEX HF 1400 SET PRISMAFLEX MONITOR PRISMAFLEX M60 SET PRISMAFLEX M100 SET DIACLEAR Prismaflex ST set (ST60/ST100/ST150 sets) PRISMAFLEX TPE 2000 SET PRISMA TPE 2000 SET PRISMAFLEX M150 SET

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device