EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000003826 · Poland · Gliwice
EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: Luna EMG.
Among these devices, 6 are declared active, 5 with a measuring function.
Devices declared under this manufacturer
- Luna EMG
- Meissa OT Pro
- Meissa OT Ultra
- Mezos SIT
- Sidra LEG Pro
- Sidra LEG Ultra
Catalogue references include Luna EMG, Meissa OT Pro, Meissa OT Ultra, Mezos SIT, Sidra LEG Pro, Sidra LEG Ultra.
European nomenclature codes declared: Y0504, V08020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0015/4038/2023 | issued | 2026-11-27 |