BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    HTL-STREFA S.A.

    Reg #: 9613304 · FEI: 3004034544 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    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
    K232509

    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
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)