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Sign in to claim this brandHTL STREFA S A
Poland·PL-MF-000002198
Last updated May 27, 2026
What HTL STREFA S A makes
HTL Strefa S.A. manufactures single-use and reusable medical devices for blood collection and injection, including blood lancets, autoinjector needles, insulin syringes (both basic and safety variants), hypodermic needles, general-purpose syringes, manual blood lancing devices, and needle guards. Their portfolio also includes insulin syringes with drop protection and safety lancets designed to reduce needle-stick injuries. Examples include the Clickfine series, Acti-Lance safety lancets, Medlance Plus, and DropSafe variants for insulin administration and blood sampling.
The company’s devices are regulated under EU Medical Device Regulations (Class I and Class II/IIa), with listings in the EUDAMED database, as well as FDA submissions via 510(k) and UDI registries. Their products are distributed globally, adhering to both European and U.S. regulatory frameworks for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does HTL Strefa S.A. manufacture?
HTL Strefa S.A. specializes in devices for blood collection and injection, including single-use and reusable options. Their portfolio covers blood lancets (both single-use and reusable manual devices), autoinjector needles, insulin syringes (basic and safety variants), hypodermic needles, general-purpose syringes, and needle guards. Examples include the Clickfine series for insulin administration, Acti-Lance and Medlance Plus safety lancets, and DropSafe variants designed to minimize needle-stick risks.
Where is HTL Strefa S.A. based, and how does this affect their regulatory compliance?
HTL Strefa S.A. is based in Poland, which means their devices are subject to both European and U.S. regulatory frameworks. Under EU Medical Device Regulations, their products fall into Class I or Class II/IIa classifications, requiring compliance with EUDAMED listings. Additionally, their devices are registered in the FDA’s 510(k) and UDI systems, demonstrating adherence to U.S. medical device regulations.
Which regulatory databases list HTL Strefa S.A.’s medical devices?
HTL Strefa S.A.’s devices are listed in multiple regulatory databases to ensure transparency and compliance. Their products appear in the EUDAMED database under EU Medical Device Regulations, as well as in the FDA’s 510(k) pre-market notification system and UDI (Unique Device Identification) registry. These listings reflect their global distribution and adherence to both European and U.S. regulatory standards.
How are HTL Strefa S.A.’s devices classified under medical device regulations?
HTL Strefa S.A.’s devices are classified under EU Medical Device Regulations primarily as Class I (low-risk) or Class II/IIa (moderate-risk), depending on their intended use and potential risk to patients. For example, single-use blood lancets and general-purpose syringes typically fall under Class I, while safety lancets or insulin syringes with additional features may qualify as Class II/IIa. This classification determines the regulatory requirements they must meet, such as conformity assessments and post-market surveillance.
What distinguishes HTL Strefa S.A.’s insulin syringes and lancets from other manufacturers?
HTL Strefa S.A. offers insulin syringes and lancets with specific safety and usability features. Their insulin syringes include variants like the droplet series and DropSafe models, which incorporate drop protection to prevent insulin loss during administration. For lancets, they provide safety designs (e.g., Acti-Lance and Medlance Plus) that reduce needle-stick injuries by retracting or guarding the needle after use. These innovations align with their focus on minimizing user risk and improving patient convenience.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Poland
- Address
- 7, Adamówek, Ozorków, Poland
- Website
- www.htl-strefa.com
- —
- —
- [email protected]
- Phone
- +48 664140189
- PRRC Contact
- Justyna Żemigała
- EUDAMED SRN
- PL-MF-000002198
- FDA FEI Number
- —
- DUNS Number
- 422528088
Catalogue (378)
Page 5 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| droplet® pen needles | 31Gx5mm | FDA UDI | Class II | Active |
| DropSafe® Insulin Safety Syringe with Fixed Needle | 0.3ml 31G x 6mm | FDA UDI | Class II | Active |
| droplet insulin syringes | 0.3ml, 30G x 12.5 mm | FDA UDI | Class II | Active |
| LEADER, pen needles | 31G x 8 mm | FDA UDI | Class II | Active |
| droplet insulin syringe | 1.0ml, 29G x 12mm | FDA UDI | Class II | Active |
| Medlance Plus, safety lancet | Special, blade 0.8 mm 2.0 mm | EUDAMEDFDA UDI | Class II | Active |
| droplet® pen needles | 29G x 10mm | FDA UDI | Class II | Active |
| Droplet Acti-Lance, safety lancets | 28G x 1.5mm | FDA UDI | Class II | Active |
| Acti-Lance, safety lancet | Special, 17G | FDA UDI | Class II | Active |
| Acti-Lance, safety lancet | Special, 17G | FDA UDI | Class II | Active |
| DropSafe MediSafe Solo, safety lancets | 29G | FDA UDI | Class II | Active |
| droplet insulin syringe | 1ml, 30G x 12.5mm | FDA UDI | Class II | Active |
| DropSafe Acti-Lance, safety lancets | 28G x 1.5 mm | FDA UDI | Class II | Active |
| droplet® pen needles | 32G x 5 mm | FDA UDI | Class II | Active |
| droplet® pen needles | 32G x 4mm | FDA UDI | Class II | Active |
| droplet®, pen needles | 32G x 4 mm | FDA UDI | Class II | Active |
| Droplet® insulin syringe | 0.5ml, 31G x 8 mm | FDA UDI | Class II | Active |
| droplet insulin syringes | 1ml, 31G x 8 mm | FDA UDI | Class II | Active |
| droplet® pen needles | 29G x 12 mm | FDA UDI | Class II | Active |
| DropSafe Syringe with Safety Needle | 23G x 3 ml | FDA UDI | Class II | Active |
| DropSafe® Insulin Safety Syringe with Fixed Needle | 1ml 31G x 6mm | FDA UDI | Class II | Active |
| ProAdvantage, safety lancets | 28G x 1.2mm | FDA UDI | Class II | Active |
| droplet insulin syringe | 0.5ml, 30G x 12.5mm | FDA UDI | Class II | Active |
| DropSafe® Insulin Safety Syringe with Fixed Needle | 0.5ml 31G x 8mm | FDA UDI | Class II | Active |
| Safe-T-Lance Plus, safety lancets | 21G x 1.8mm | FDA UDI | Class II | Active |
| Safe-T-Lance Plus, safety lancets | 1.5mm x 1.2mm | FDA UDI | Class II | Active |
| droplet insulin syringe | 0.5ml, 29G x 12mm | FDA UDI | Class II | Active |
| droplet insulin syringe | 0.3ml, 30G x 12.5mm | FDA UDI | Class II | Active |
| Droplet® insulin syringe | 0.5ml, 31 x 6mm | FDA UDI | Class II | Active |
| droplet insulin syringe | 0.3ml, 29G x 12mm, | FDA UDI | Class II | Active |
| droplet insulin syringe | 0.5ml, 31G x 8mm | FDA UDI | Class II | Active |
| droplet Genteel lancing device | n/a | FDA UDI | Class II | Active |
| MedicoFINE | 8179 | EUDAMED | Class IIa | Active |
| Sicherheits-Pen-Nadeln | 7549 | EUDAMED | Class IIa | Active |
| AviFine | 7727 | EUDAMED | Class IIa | Active |
| Clickfine | 7792 | EUDAMED | Class IIa | Active |
| Accu-Fine | 8846 | EUDAMED | Class IIa | Active |
| Clickfine | 7791 | EUDAMED | Class IIa | Active |
| Droplet Pen Needle 30G & 33G | K202340 | FDA 510(k) | Class II | Active |
| Droplet Pen Needles | K143437 | FDA 510(k) | Class II | Active |
| DropSafe Safety Pen Needle | K170988 | FDA 510(k) | Class II | Active |
| DropSafe 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 Lancets | K220643 | FDA 510(k) | Class II | Active |
| Droplet Pen Needle 34G | K192082 | FDA 510(k) | Class II | Active |
| droplet® personal lancets | K250016 | FDA 510(k) | Class II | Active |
| Droplet Pen Needle | K171982 | FDA 510(k) | Class II | Active |
| Accu-Fine | 7899 | EUDAMED | Class IIa | Active |
| Haemolance Plus | 7374 | EUDAMEDFDA UDI | Class IIa | Active |
| MediSafe Solo | 7130 | EUDAMEDFDA UDI | Class IIa | Active |
| Solofix Safety | 7133 | EUDAMED | Class IIa | Active |
| Single-Let | 9036 | EUDAMED | Class IIa | Active |
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