BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    LINEA ASPIRAZIONE XTRA

    Reg #: 9680841 · FEI: 3005426550 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SORIN GROUP ITALIA S.R.L
    Registration Number
    9680841
    FEI Number
    3005426550
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    86, VIA STATALE 12 NORD
    City
    MIRANDOLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K101586

    Owner / Operator

    Firm Name
    SORIN GROUP ITALIA S.R.L
    Operator Number
    9011842
    Address
    86, VIA STATALE 12 NORD, --
    City
    MIRANDOLA (MO)
    State
    Modena
    Postal Code
    41037
    Country
    IT
    Correspondent
    LUIGI - VECCHI

    Products

    Device Name Product Code
    Apparatus, Autotransfusion CAC

    Proprietary Names

    LINEA ASPIRAZIONE XTRA PROCEDURE SET TX/125 BOWL SET X/55 PROCEDURE SET BX/55 BOWL SET X/125 BOWL SET X/225 PROCEDURE SET TX/175 PROCEDURE SET TX/225 PROCEDURE SET BX/175 PROCEDURE SET BX/225 BOWL SET X/175 PROCEDURE SET BX/125 PROCEDURE SET TX/55 XTRA Autotransfusion Cell Separator COLLECTION SET TX CARDIO COLLECTION SET TX SEQUESTRATION SET X XRES T with preconnected cardio kit COLLECTION SET BX COLLECTION SET BX CARDIO

    Establishment Types

    Manufacture Medical Device