BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DropSafe Haemolance Plus Safety Lancets

    Reg #: 3006142663 · FEI: 3006142663 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HTL-STREFA, INC.
    Registration Number
    3006142663
    FEI Number
    3006142663
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    113 Towne Lake Pkwy Ste 120
    City
    Woodstock
    State
    GA
    ZIP
    30188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220643

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

    Proprietary Names

    DropSafe Haemolance Plus Safety Lancets DropSafe ergoLance Safety Lancets DropSafe Prolance Safety Lancets DropSafe Medlance Plus Safety Lancets droplet ACTI-LANCE Safety Lancets droplet MEDLANCE PLUS Safety Lancets MINICOLLECT LANCELINO Safety Lancets DropSafe MediSafe Solo Safety Lancets DropSafe Acti-Lance Safety Lancets

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198