"STERIPACK MEDICAL POLAND" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000006939 · Poland · Jelcz-Laskowice
"STERIPACK MEDICAL POLAND" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: 23G x 1\.
Among these devices, 5 are declared sterile.
Devices declared under this manufacturer
- Safety Needle
Catalogue references include 7527942002, 7527942019, 7527942064, 7527942071, 7527942187.
European nomenclature codes declared: A0101010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 100.0 % |
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. "STERIPACK MEDICAL POLAND" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44910120405 | supplemented | 2030-08-05 |