PARAMEDYK Sp. z o.o.
PL-MF-000004192 · Poland · Marki
PARAMEDYK Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: NR-TM-D, OW-1, splint_50, splint_91.
Among these devices, 3 are declared sterile.
Devices declared under this manufacturer
- Battle Chest Seal BCS Vented
- Battle Chest Seal BCS Vented 2Pack
- Battle Chest Seal BCS Vented Blue
- Bawełniana chusta trójkątna
- Gaza wypełniająca Tactical Compressed Gauze
- HIPO BLANKET 3L
- Nożyczki ratownicze Tactical MED duże
- Nożyczki ratownicze Tactical MED małe
- Opatrunek Indywidualny W
- Szyna Splint 50cmx11cm
- Szyna Splint 91cmx50cm
Catalogue references include BCS-V-03-2P, BCS-V-3B, HB-3L, NR-TM-D, NR-TM-M, OW-1.
European nomenclature codes declared: M0499, M03050202, L01040199, T030399, M040499, M020199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| 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 | 11 |
|---|---|
| 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. PARAMEDYK Sp. z o.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1434-MDR-005/2026 | issued | 2031-04-09 |