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 810, Type 553-556, type 820, type 810, Type 420.
Among these devices, 431 are declared sterile, 2 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023950-1 | issued | 2029-08-01 |