Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613304

FEI Number

3004034544

Entity Name

HTL-STREFA S.A.

City/State/Country

OZORKOW Lodzkie, PL

Establishment Address

ADAMOWEK 7, OZORKOW Lodzkie 95-035, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered 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 personal lancets 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	1996-10-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-10-21
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-05-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-03-28
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-11-15
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-12-13
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-09-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-05-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-07-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-01-16
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-06-13
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-02-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-06-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-01-28
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	2025-12-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-07-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-07-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-01-27
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-06-13
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-06-13

Official Correspondent

Justyna Zemigala

US Agent Details

Sylvie Verdon Business: HTL-Strefa, Inc. Email: sylvie.verdon@htl-strefa.com Phone: (770) 5280410

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
3006142663	HTL-STREFA, INC.	Woodstock, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613304. Last updated year: 2026. Please use registration number 9613304 when referencing this establishment in official correspondence.