BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Ascensia Diabetes Care Poland Sp. z o.o.

    Reg #: 3038419886 · FEI: 3038419886 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    42
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Ascensia Diabetes Care Poland Sp. z o.o.
    Registration Number
    3038419886
    FEI Number
    3038419886
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Aleje Jerozolimskie 142B, Warszawa
    City
    Warszawa Mazowieckie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K241787
    PMA Number
    P150001

    Owner / Operator

    Firm Name
    Ascensia Diabetes Care Holdings AG
    Operator Number
    10050965
    Address
    5 WOOD HOLLOW RD
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US

    US Agent

    Business Name
    ASCENSIA DIABETES CARE HOLDINGS AG
    Contact Name
    Brian Truchan
    Address
    5 Woodhollow Rd
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US
    Email
    [email protected]
    Phone
    914 3563140

    Products

    Device Name Product Code
    Automated Insulin Dosing , Threshold Suspend OZO
    System, Test, Blood Glucose, Over The Counter NBW
    Automated Insulin Dosing Device System, Single Hormonal Control OZP
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Dehydrogenase, Glucose LFR
    Calculator/Data Processing Module, For Clinical Use JQP
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL

    Proprietary Names

    Contour Next Link 2.4 Wireless Blood Glucose Monitoring System Contour Next Blood Glucose Test Strips Contour Next Link 2.4 Wireless Blood Glucose Meter CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System CONTOUR® NEXT GEN Blood Glucose Monitoring System CONTOUR NEXT LINK 2.4 CONTOUR PLUS LINK 2.4 Glucofacts Deluxe Diabetes Management Software MICROLET®NEXT Lancets Contour Next Blood Glucose Monitoring System Contour Next Blood Glucose Meter Contour Next Control Solution Contour Next ONE Blood Glucose Monitoring System Contour Next Link Blood Glucose Meter Contour Next Link Blood Glucose Monitoring System Contour Next Control Solutions Contour Control Solution Contour Next EZ Blood Glucose Meter Contour Next USB Blood Glucose Monitoring System Contour Next EZ Blood Glucose Monitoring System Contour Next USB Blood Glucose Meter Contour Next LINK Wireless Blood Glucose Meter Contour Next LINK Wireless Blood Glucose Monitoring System Contour Next ONE Blood Glucose Meter Glucofacts Deluxe Diabetes Management System CONTOUR® PLUS BLUE Blood Glucose Monitoring System CONTOUR® NEXT ONE Blood Glucose Monitoring System Contour Next Link Wireless Blood Glucose Meter Ketostix, Keto-Diastix Contour Contour TS Contour® next GEN Blood Glucose Monitoring System MICROLET NEXT lancing device, MICROLET Lancet Diastix Keto-Diastix CONTOUR NEXT ONE CONTOUR PLUS CONTOUR NEXT CONTOUR NEXT LINK CONTOUR NEXT EZ CONTOUR PLUS ONE CONTOUR PLUS LINK

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility