EnSafe sp.z o.o.
PL-MF-000042856 · Poland · Zabierzów
EnSafe sp.z o.o. is registered in the European database on medical devices as a manufacturer, with 207 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 207 |
|---|
Most frequent device types declared: EVACUATION CHAIR, Prześcieradło ewakuacyjne / Evacuation Sheet, Transportation Chair / Krzesło transportowe.
Among these devices, 129 are declared active.
Devices declared under this manufacturer
- Bariatric mattress Hulk
- Basic
- Comfort
- EasyMove
- Everest 2.0
- Krzesło transportowe Reptor
- Mini Rescue 2
- Mini Rescue 6
- Prime
- Reptor
- Rescue
- Robin 2.0
Showing 12 of 207 declared devices.
Catalogue references include K.E2.009, K.E2.054, K.E2.096, K.R2.007, K.R2.028, K.R2.031.
European nomenclature codes declared: Y99.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 207 |
| 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 | 207 |
|---|---|
| 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. EnSafe sp.z o.o. was not found in either the U.S. or the Canadian register.