BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    HTL-STREFA S.A.

    Reg #: 9613304 · FEI: 3004034544 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    35
    Establishment Types
    5
    Classifications
    8

    Registration Details

    Registration Name
    HTL-STREFA S.A.
    Registration Number
    9613304
    FEI Number
    3004034544
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ADAMOWEK 7
    City
    OZORKOW Lodzkie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K202340

    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
    Needle, Hypodermic, Single Lumen FMI
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Syringe, Antistick MEG
    Continuous Measurement Thermometer FLL
    Syringe, Piston FMF
    Tape And Bandage, Adhesive KGX
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    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 Droplet 33G Droplet 30G droplet pen needle 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 DropSafe® Insulin Safety Syringe with Fixed Needle DropSafe Syringe with Safety Needle droplet INSULIN SYRINGE Droplet 34G DropSafe Safety Pen Needle 5mm Droplet Genteel Lancing Device Clickfine pen needles DropSafe Safety Needle DropSafe® Inject-Safe Barrier Bandage ™ DropSafe Safety Pen Needle

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor