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: PTS 2000, PTS 925 W, REVO 60, REVO 60, REVO 80, REVO nx, REVO nx 130, REVO 80.
Among these devices, 24 are declared active, 18 with a measuring function.
Devices declared under this manufacturer
- PTS 2000
- PTS 920
- PTS 920 BY
- PTS 925 W
- REVO 60
- REVO nx
- REVO nx 130
- SOCT
- Spectral Optical Coherence Tomographer REVO 60
- Spectral Optical Coherence Tomographer REVO 80
- Spectral Optical Coherence Tomographer REVO FC
- Spectral Optical Coherence Tomographer REVO nx 130
Showing 12 of 24 declared devices.
Catalogue references include 21.5.0, REF 190-80, REF 191-60, REF 192-110, REF 192-130, REF 760-001.
European nomenclature codes declared: Z12120121, Z12120182, Z1212012003, Z1212012082, Z12120180.
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 |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 16.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OPTOPOL TECHNOLOGY SP. Z.O.O. |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2017-10-20 |
Licence types: Device Family (2), Single Device (1).
Licensed under: SPECTRAL OPTICAL COHERENCE TOMOGRAPHER, AUTOMATED PROJECTION PERIMETER PTS 2000, AUTOMATED PERIMETER.
North American profile: Both markets. OPTOPOL Technology Sp. z o.o. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
DZ 1497914-1 | issued | 2029-10-29 |