HTL-Strefa S.A.
PL-MF-000002198 · Poland · Ozorków
HTL-Strefa S.A. is registered in the European database on medical devices as a manufacturer, with 434 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 434 |
|---|
Most frequent device types declared: Type 420, Type 553-556, Type 560, Type 610, Type 810.
Among these devices, 431 are declared sterile, 2 active.
Devices declared under this manufacturer
- Accu-Fine
- Acti-Lance
- Haemofine
- Medisafe Solo
- Medlance Plus, safety lancet
- Penlancet
- Prolance
- Safe Block
- Single-let
- diamet mySafety
- dropfeel
- droplet
Showing 12 of 434 declared devices.
Catalogue references include 4006, 4008, 4031, 4049, 7493, 8003.
European nomenclature codes declared: V010401, A0101010202, V010402, A0101010201, V9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HTL-STREFA S.A. (PL) · FDA 9613304 |
| Devices in EUDAMED | 434 |
| Country of registration | Poland |
Device-level evidence
| Devices with a numeric GTIN | 414 |
|---|---|
| Found in the U.S. device database | 55 |
| Share | 13.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HTL-STREFA S.A. |
North American profile: Both markets. HTL-Strefa S.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023950-1 | issued | 2029-08-01 |