BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    INSPIRE HVR DUAL

    Reg #: 9680841 · FEI: 3005426550 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    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
    K122844

    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
    Oxygenator, Cardiopulmonary Bypass DTZ
    Reservoir, Blood, Cardiopulmonary Bypass DTN

    Proprietary Names

    INSPIRE HVR DUAL INSPIRE 8F M INSPIRE 8F DUAL

    Establishment Types

    Manufacture Medical Device