BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    SOL-GUARD™ Safety Pull-Button Blood Collection Set

    Reg #: 3012461436 · FEI: 3012461436 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sol-Millennium Europe Sp. z o. o.
    Registration Number
    3012461436
    FEI Number
    3012461436
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Twarda 18
    City
    Warsaw Mazowieckie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K213718

    Owner / Operator

    Firm Name
    Sol-Millennium
    Operator Number
    10035370
    Address
    311 S Wacker Drive, Suite 4100
    City
    Chicago
    State
    IL
    Postal Code
    60606
    Country
    US
    Correspondent
    Edward C Roles

    US Agent

    Business Name
    SOL-MILLENNIUM
    Contact Name
    Edward Roles
    Address
    311 S Wacker Drive, Suite 4100
    City
    Chicago
    State
    IL
    ZIP
    60606
    Country
    US
    Email
    [email protected]
    Phone
    773 8376560

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    SOL-GUARD™ Safety Pull-Button Blood Collection Set

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device