BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Sol-Care Safety Blood Collection Needle

    Reg #: 3012461436 · FEI: 3012461436 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    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
    K182146

    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
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Sol-Care Safety Blood Collection Needle Sol-M Holder with Male Luer Lock Adapter SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder Sol-M Blood Collection Needles Sol-M Multi Sample Needle Sol-M Luer Adapter Sol-M Blood Collection Set Sol-Care Safety Blood Collection Needle with holder SOL-M Blood Transfer SOL-CARE Safety Multi-Sample Needle SOL-M Blood Collection Tube Holder

    Establishment Types

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