BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Kidney Assist Transport Perfusion Set

    Reg #: 3021739803 · FEI: 3021739803 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    XVIVO BV
    Registration Number
    3021739803
    FEI Number
    3021739803
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bornholmstraat 84
    City
    Groningen
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K211333

    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
    3615 South Huron Street
    City
    Englewood
    State
    CO
    ZIP
    80110
    Country
    US
    Email
    [email protected]
    Phone
    720 9007298

    Products

    Device Name Product Code
    System, Perfusion, Kidney KDN

    Proprietary Names

    Kidney Assist Transport Perfusion Set Kidney Assist Transport

    Establishment Types

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