BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    droplet pen needle

    Reg #: 9613304 · FEI: 3004034544 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HTL-STREFA S.A.
    Registration Number
    9613304
    FEI Number
    3004034544
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ADAMOWEK 7
    City
    OZORKOW Lodzkie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K143437

    Owner / Operator

    Firm Name
    HTL-STREFA S.A.
    Operator Number
    9028458
    Address
    ADAMOWEK 7, --
    City
    OZORKOW
    State
    PL-NOTA
    Postal Code
    95-035
    Country
    PL
    Correspondent
    Justyna - Zemigala

    US Agent

    Business Name
    HTL-Strefa, Inc.
    Contact Name
    Sylvie Verdon
    Address
    113 Towne Lake Pkwy
    City
    Woodstock
    State
    GA
    ZIP
    30188
    Country
    US
    Email
    [email protected]
    Phone
    770 5280410

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    droplet pen needle

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198