BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HaemoFine

    Reg #: 3006142663 · FEI: 3006142663 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    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

    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

    HaemoFine MediSafe SOLO ergoLance HAEMOLANCE Plus Safe-T-Lance Plus Acti-Lance MEDLANCE plus MEDLANCE HAEMOLANCE droplet personal lancets PROLANCE droplet lancing device Acti-Lance baby

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198