BEUDAMED
    FDA Registration Active 🇸🇰 Slovakia

    MEDOJECT fine Pen Needles

    Reg #: 3008272066 · FEI: 3008272066 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CHIRANA T.INJECTA, A.S.
    Registration Number
    3008272066
    FEI Number
    3008272066
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Nam. Dr. A.Schweitzera 194
    City
    Stara Tura Trenciansky
    Country
    SK

    Regulatory Submissions

    510(k) Number
    K220614

    Owner / Operator

    Firm Name
    CHIRANA T.Injecta, a.s.
    Operator Number
    10046566
    Address
    Nam. Dr. A.Schweitzera 194
    City
    Stara Tura
    State
    Trenciansky
    Postal Code
    916 01
    Country
    SK
    Correspondent
    Rastislav Broska

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 2545756

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    MEDOJECT fine Pen Needles

    Establishment Types

    Manufacture Medical Device