BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U

    Reg #: 3006849754 · FEI: 3006849754 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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
    K212341

    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
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)