BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    XVIVO PERFUSION AB

    Reg #: 3007710603 · FEI: 3007710603 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    XVIVO PERFUSION AB
    Registration Number
    3007710603
    FEI Number
    3007710603
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Entreprenorsstraket 10
    City
    Molndal Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K170826
    PMA Number
    P180014

    Owner / Operator

    Firm Name
    XVIVO Perfusion AB
    Operator Number
    10029831
    Address
    Entreprenorsstraket 10
    City
    Mölndal
    State
    Vastra Gotaland
    Postal Code
    43153
    Country
    SE

    US Agent

    Business Name
    XVIVO Perfusion INC
    Contact Name
    Sara Garton
    Address
    16080 Table Mountain Pkwy Ste 500
    City
    Golden
    State
    CO
    ZIP
    80403
    Country
    US
    Email
    [email protected]
    Phone
    720 9007298

    Products

    Device Name Product Code
    System, Perfusion, Kidney KDN
    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs PHO
    System/Device, Pharmacy Compounding NEP

    Proprietary Names

    Perfadex Plus XPS Disposable Lung Circuit XVIVO Organ Chamber XVIVO PGM STEEN Solution XVIVO Disposable Kit XPS XVIVO Lung Cannula Set XVIVO Click Adapter REF 19024

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility