BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GAMBRO DIALYSATOREN GMBH

    Reg #: 9611369 · FEI: 3002807035 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    7

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    Registration Details

    Registration Name
    GAMBRO DIALYSATOREN GMBH
    Registration Number
    9611369
    FEI Number
    3002807035
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HOLGER - CRAFOORD - STRASSE 26
    City
    HECHINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K213639

    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
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Hemodialyzer, Re-Use, High Flux MSF
    Dialyzer, Capillary, Hollow Fiber FJI
    Hemodialyzer With Expanded Solute Removal Profile QAX
    Apparatus, Hemoperfusion, Sorbent FLD

    Proprietary Names

    Revaclear 300 Revaclear 500 Revaclear 400 U9000 Ultrafilter AK 98 Dialysis Machine C-705 Accessory Expansion Chamber U9000 Plus Ultrafilter Revaclear POLYFLUX 140H, 170H, 210H POLYFLUX 14L, 17L, 21L POLYFLUX HEMODIALYZER MODEL 6H Theranova Dialyzers (Theranova 400, Theranova 500) MARS Monitor ITC US, MARS Treatment Kit Type 1116/1 - X-MARS US, Prismaflex Control Unit

    Establishment Types

    Manufacture Medical Device