BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    EUROTROL B.V.

    Reg #: 9681518 · FEI: 3005695774 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    56
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    EUROTROL B.V.
    Registration Number
    9681518
    FEI Number
    3005695774
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KEPLERLAAN 20
    City
    EDE Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K060215

    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Control, Hemoglobin GGM
    Controls For Blood-Gases, (Assayed And Unassayed) JJS
    Plasma, Coagulation Control GGN
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Control, Hematocrit GLK
    Instrument, Hematocrit, Automated GKF
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    AlbuTrol, Level 2 - 1890202 AlbuTrol, Level 1 - 1890102 HemoTrol, Level 3 - 1710302 HemoTrol, Level 1 - 1710102 HemoTrol, Level 2 - 1710202 CueSee Hypoxic HYPERBARIC QC - 1640204 CueSee® Coag 3 CueSee® Coag 1 CueSee® Coag 4 CueSee® Coag 5 CueSee® Coag 2 Glucotrol-NG, Level 3 - 1700302 GlucoTrol-AQ - 1801302 Glucotrol-NG, Level 4 - 1700402 Glucotrol-NG, Level 2 - 1700202 Eurotrol epoc GAS-ISE Metabolites – Level 2 - 2660210 Eurotrol epoc GAS-ISE Metabolites – Level 3 - 2660310 Eurotrol epoc GAS-ISE Metabolites – Level 1 - 2660110 Eurotrol epoc GAS-ISE Metabolites – Level 6 - 2660610 Eurotrol® epoc® Calibration Verification Fluids - 2670005 GlucoLin - 0250005 Eurotrol Hb301 Control - Level 1 - 1880102 Eurotrol Hb301 Control - Level 2 - 1880202 Eurotrol Hb301 Control - Level 3 - 1880302 Eurotrol Hct Control, Level A - 1950210 Eurotrol Hct Control, Level C - 1950310 Eurotrol Hct Control, Level B - 1950410 epoc Hematocrit Verification Fluids - 1900005 CueSee® VeriSTAT QC, Level 3 - 2210310 CueSee® VeriSTAT QC, Level 1 - 2210110 CueSee® VeriSTAT LVM - 2200005 CueSee® VeriSTAT QC, Level 2 - 2210210 CueSee® Hyperbaric CSR 1 CueSee VeriSTAT® S2 CueSee VeriSTAT® S3 CueSee® BGEM 1 2 3 4 5 CueSee VeriSTAT® S1 CueSee VeriSTAT® LV CueSee® BGEM 3 CueSee® BGEM 2 CueSee® BGEM 1 HemoTrol Duo High HemoTrol Duo Low HemoTrol Duo Normal CueSee® CO-OX LVB CueSee® CO-OX S4B CueSee® CO-OX S2B CueSee® CO-OX S1A CueSee® CO-OX S3A CueSee® CO-OX S5B CueSee® CO-OX LVA CueSee® CO-OX S1B CueSee® CO-OX S3B CueSee® CO-OX S5A CueSee® CO-OX S6B

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)