Topsil Med Spółka z Ograniczoną Odpowiedzialnością
PL-MF-000036040 · Poland · Słubica B
Topsil Med Spółka z Ograniczoną Odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Devices declared under this manufacturer
- Blizcare
Catalogue references include 8SP-0029, 8SP-0031, 8SP-0032, 8SP-0039, 8SP-0043, 8SP-0044.
European nomenclature codes declared: M04010203, M9002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| 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 | 12 |
|---|---|
| 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. Topsil Med Spółka z Ograniczoną Odpowiedzialnością was not found in either the U.S. or the Canadian register.