Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006142663

FEI Number

3006142663

Entity Name

HTL-STREFA, INC.

City/State/Country

Woodstock, GA, US

Establishment Address

113 Towne Lake Pkwy Ste 120, Woodstock, GA 30188, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

HTL-STREFA S.A. (Owner Number: 9028458)

Owner / Operator Contact Address

ADAMOWEK 7, --, OZORKOW, PL-NOTA 95-035, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220643

PMA Number

N/A

All Registered 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 droplet personal lancets 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-11-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-07-21
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2020-08-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-09-22
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2020-09-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-09-22
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-09-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-11-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-02-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-07-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-10-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-12-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-01-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-07-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-03-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-11-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-12-20
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	1996-10-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-05-15
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-05-05
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-01-27
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-11-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HTL-STREFA S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9613304	HTL-STREFA S.A.	OZORKOW Lodzkie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006142663. Last updated year: 2026. Please use registration number 3006142663 when referencing this establishment in official correspondence.