BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    CueSee® VeriSTAT QC, Level 2 - 2210210

    Reg #: 9681518 · FEI: 3005695774 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EUROTROL B.V.
    Registration Number
    9681518
    FEI Number
    3005695774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KEPLERLAAN 20
    City
    EDE Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K131595

    Owner / Operator

    Firm Name
    EUROTROL B.V.
    Operator Number
    9023488
    Address
    KEPLERLAAN 20, --
    City
    EDE
    State
    Gelderland
    Postal Code
    NL 6716 BS
    Country
    NL

    US Agent

    Business Name
    EUROTROL INC.
    Contact Name
    Bart Maas
    Address
    850 N Black Branch Rd
    City
    Elizabethtown
    State
    KY
    ZIP
    42701
    Country
    US
    Email
    [email protected]
    Phone
    502 5011180

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    CueSee® VeriSTAT QC, Level 2 - 2210210 CueSee® VeriSTAT LVM - 2200005 CueSee® VeriSTAT QC, Level 1 - 2210110 CueSee® VeriSTAT QC, Level 3 - 2210310

    Establishment Types

    Manufacture Medical Device