PRAGMA SYSTEM SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000041743 · Poland · Wrocław
PRAGMA SYSTEM SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 24 |
|---|
Most frequent device types declared: Kamizelka Pragma Comfort, Orczyk rehabilitacyjno - transportowy Pragma, Zblocze pojedyncze.
Among these devices, 16 are declared active.
Devices declared under this manufacturer
- Kamizelka Pragma Comfort
- Kamizelka Pragma Comfort MINI
- Orczyk rehabilitacyjno - transportowy Pragma, REHFIX-1
- Orczyk rehabilitacyjno - transportowy Pragma, REHFIX-2
- Orczyk rehabilitacyjno - transportowy Pragma, REHFIX-4
- PRAGMA SYSTEM - URZĄDZENIE DO REHABILITACJI, PIONIZACJI I REEDUKACJI C
- PRAGMA SYSTEM HOME, PS.5G.HOME.L
- PRAGMA SYSTEM HOME, PS.5G.HOME.M
- PRAGMA SYSTEM HOME, PS.5G.HOME.S
- PRAGMA SYSTEM HOME, PS.5G.HOME.XL
- PRAGMA SYSTEM PRO, PS.5G.PRO.A
- PRAGMA SYSTEM URZĄDZENIE DO REHABILITACJI, PIONIZACJI I REEDUKACJI CHO
Showing 12 of 24 declared devices.
Catalogue references include 5907990944381, P4G.23.00, PS.4G.HOME.S, PS.5G.HOME.S, PS.5G.HOME.XL, PS.5G.PRO.A.
European nomenclature codes declared: Y050201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| 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 | 24 |
|---|---|
| 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. PRAGMA SYSTEM SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.