POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000037042 · Poland · CIESZYN
POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 27 |
|---|
Most frequent device types declared: FWC, Ophthalmic Table SE1, Ophthalmic Unit Comfort Maxi R.
Among these devices, 25 are declared active.
Devices declared under this manufacturer
- Fotel wolnostojący Comfort
- Stolik Okulistyczny SE1K
- Stolik Okulistyczny SE2
- Stolik szkoleniowy
- Unit Okulistyczny Comfort Maxi EL
- Unit Okulistyczny Comfort Maxi R
- Unit Okulistyczny Comfort Plus EL
- Unit Okulistyczny Comfort Plus ER
- Unit Okulistyczny Comfort Plus L
- Unit Okulistyczny Comfort Plus R
- Unit Okulistyczny Comfort R
- Unit Okulistyczny Mini L
Showing 12 of 27 declared devices.
Catalogue references include SE2, UN2CL, UN2D, UN3A, UN3B, UN3E.
European nomenclature codes declared: Z12129001, V08020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 27 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.