OPTOPOL Technology Sp. z o.o.
PL-MF-000004770 · Poland · Zawiercie
OPTOPOL Technology Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|
Most frequent device types declared: REVO 60, REVO 80, REVO nx, REVO nx 130, REVO HR, REVO FC, REVO FC 130, REVO 60, REVO nx, PTS 2000.
Among these devices, 24 are declared active, 18 with a measuring function.
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 | OPTOPOLTechnology Sp. z o.o. (PL) · FDA 3006853861 |
| Devices in EUDAMED | 24 |
| Country of registration | Poland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
DZ 1497914-1 | issued | 2029-10-29 |