BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    REF: HX22W-S0 (Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4)

    Reg #: 3006849754 · FEI: 3006849754 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERIL VERONA s.r.l.
    Registration Number
    3006849754
    FEI Number
    3006849754
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via San Giuseppe, 31
    City
    ERBE Verona
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K223879

    Owner / Operator

    Firm Name
    STERIL VERONA s.r.l.
    Operator Number
    10023713
    Address
    Via San Giuseppe, 31
    City
    ERBE'
    State
    Verona
    Postal Code
    37060
    Country
    IT
    Correspondent
    Ottavio De Santi

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Heat-Exchanger, Cardiopulmonary Bypass DTR

    Proprietary Names

    REF: HX22W-S0 (Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4) REF: HX11W-S1M (Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 M) REF: HX11W-S0 (Quantum PureFlow Standard Heat Exchanger Low Flow 3/16) REF: HX11W-S2M (Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M) REF: HX55W-S0 (Quantum PureFlow Standard Heat Exchanger High Flow 3/8) REF: HX22W-S1 (Quantum PureFlow Standard Heat Exchanger Medium Flow 3/8) REF: HX11W-S1 (Quantum PureFlow Standard Heat Exchanger Low Flow 1/4) REF: HX11W-S2 (Quantum PureFlow Standard Heat Exchanger Low Flow 3/8)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)