BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    CLINITEK Advantus

    Reg #: 3008058135 · FEI: 3008058135 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    Kimball Electronics Poland Sp.z o.o
    Registration Number
    3008058135
    FEI Number
    3008058135
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ul. Poznanska 1 C
    City
    Tarnowo Podgorne Wielkopolskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K063276

    Owner / Operator

    Firm Name
    KIMBALL ELECTRONICS GROUP, LLC
    Operator Number
    9071700
    Address
    1205 Kimball Blvd.
    City
    Jasper
    State
    IN
    Postal Code
    47546
    Country
    US

    US Agent

    Business Name
    KIMBALL ELECTRONICS Inc.
    Contact Name
    LOLA J. Steward
    Address
    1205 Kimball Blvd.
    City
    Jasper
    State
    IN
    ZIP
    47546
    Country
    US
    Email
    [email protected]
    Phone
    812 6344172

    Products

    Device Name Product Code
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Blood, Occult, Colorimetric, In Urine JIO
    Automated Urinalysis System KQO
    Refractometer For Clinical Use JRE
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Enzymatic Method, Creatinine JFY
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Test, Urine Leukocyte LJX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT

    Proprietary Names

    CLINITEK Advantus

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)