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Data / Medical devices / Poland / Htl-Strefa S.A.

Htl-Strefa S.A.: FDA-registered device maker in OZORKOW Lodzkie, Poland, 18 510(k) clearances

Htl-Strefa S.A. is registered with the FDA (registration 9613304) in OZORKOW Lodzkie, Poland. It lists 8 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 1, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
9613304
FEI number
3004034544
Address
Adamowek 7, OZORKOW Lodzkie, Poland, 95-035
Owner or operator
HTL-STREFA S.A. (9028458)
Roles
Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Specification developer
First device listed
October 31, 1996
Registered through
2027
Brand names listed
Acti-Lance, Acti-Lance baby, Clickfine pen needles, DropSafe Acti-Lance Safety Lancets, DropSafe Haemolance Plus Safety Lancets, DropSafe MediSafe Solo Safety Lancets, DropSafe Medlance Plus Safety Lancets, DropSafe Prolance Safety Lancets and more

Devices it lists

DeviceProduct codeClassRoleSource
Continuous Measurement ThermometerFLL2Complaint file establishmentaccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Contract manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Complaint file establishment, Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureQRK2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, AntistickMEG2Complaint file establishment, Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Complaint file establishment, Foreign private label distributor, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 1, 2025K250016droplet® personal lancetsQRKSubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
July 8, 2022K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety LancetsFMKSubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
January 18, 2022K201044CHIRANA Insulin SyringesFMFSubstantially EquivalentChirana T. Injectaaccessdata.fda.gov
January 7, 2022K211716DropSafe Safety Pen NeedlesFMISubstantially EquivalentHtl Strefa SAaccessdata.fda.gov
October 15, 2020K202340Droplet Pen Needle 30G & 33GFMISubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
April 21, 2020K192082Droplet Pen Needle 34GFMISubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
May 11, 2018K180385Infrared Body ThermometerFLLSubstantially EquivalentHetaida Technology Co., Ltd.accessdata.fda.gov
March 21, 2018K171982DROPLET PEN NEEDLEFMISubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
December 12, 2017K170988DropSafe Safety Pen NeedleFMISubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
October 11, 2017K171984Clickfine Pen Needle, Penfine Classic Pen NeedleFMISubstantially EquivalentYpsomed AGaccessdata.fda.gov
August 2, 2017K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleMEGSubstantially EquivalentYangzhou Medline Industry, Co., Ltd.accessdata.fda.gov
June 17, 2016K153537Sol-M Insulin Syringe, Sol-M TB SyringeFMFSubstantially EquivalentSol-Millennium Medical, Inc.accessdata.fda.gov
May 12, 2016K153670Genteel Lancing DeviceFMKSubstantially EquivalentGenteel, LLCaccessdata.fda.gov
June 25, 2015K143437Droplet Pen NeedlesFMISubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
May 22, 2014K132681SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGEMEGSubstantially EquivalentSol-Millennium Medical, Inc.accessdata.fda.gov
May 8, 2013K123684SOL-CARE SAFETY NEEDLEFMISubstantially EquivalentSol-Millennium Medicalaccessdata.fda.gov
August 20, 2010K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)FMFSubstantially EquivalentInviro Medical Devices, Inc.accessdata.fda.gov
October 4, 2005K051783ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLESFMISubstantially EquivalentArtsana S.P.Aaccessdata.fda.gov

Compare with other makers

Updated July 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.