BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HTL-STREFA, INC.

    Reg #: 3006142663 · FEI: 3006142663 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    HTL-STREFA, INC.
    Registration Number
    3006142663
    FEI Number
    3006142663
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    113 Towne Lake Pkwy Ste 120
    City
    Woodstock
    State
    GA
    ZIP
    30188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052667

    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

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Antistick MEG
    Continuous Measurement Thermometer FLL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    Artsana Insulin Syringes DropSafe Syringe with Safety Needle Droplet Genteel Lancing Device DropSafe® Insulin Safety Syringe with Fixed Needle Safe Block Pen Needle Insupen Original Pen Needle Insupen Advanced Pen Needle Droplet 33G Droplet 30G Clickfine pen needles DropSafe Safety Pen Needle 5mm DropSafe Safety Needle droplet pen needle DropSafe Safety Pen Needle Acti-Lance MEDLANCE droplet personal lancets HAEMOLANCE Plus droplet lancing device ergoLance HaemoFine MEDLANCE plus Safe-T-Lance Plus PROLANCE MediSafe SOLO Acti-Lance baby HAEMOLANCE DropSafe® Inject-Safe Barrier Bandage ™ DropSafe Prolance Safety Lancets droplet MEDLANCE PLUS Safety Lancets DropSafe ergoLance Safety Lancets MINICOLLECT LANCELINO Safety Lancets DropSafe Acti-Lance Safety Lancets droplet ACTI-LANCE Safety Lancets DropSafe MediSafe Solo Safety Lancets DropSafe Medlance Plus Safety Lancets DropSafe Haemolance Plus Safety Lancets droplet INSULIN SYRINGE DropSafe Sicura Droplet 34G

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198