BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    ONE-CARE PRO Safety Lancets

    Reg #: 3015485283 · FEI: 3015485283 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIVENA SP. Z O.O.
    Registration Number
    3015485283
    FEI Number
    3015485283
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Aleja Jana Pawla II 27
    City
    Warszawa Mazowieckie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K222408

    Owner / Operator

    Firm Name
    MediVena Sp. z o.o.
    Operator Number
    10090324
    Address
    Aleja Jana Pawla II 27
    City
    Warszawa
    State
    Mazowieckie
    Postal Code
    00-867
    Country
    PL

    US Agent

    Business Name
    MediVena
    Contact Name
    Jaroslaw Moleda
    Address
    1 Glenlake Parkway, Suite 700
    City
    Atlanta
    State
    GA
    ZIP
    30328
    Country
    US
    Email
    [email protected]
    Phone
    404 4221513

    Products

    Device Name Product Code
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    ONE-CARE PRO Safety Lancets

    Establishment Types

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