BFM Spółka z ograniczoną odpowiedzialnością
PL-MF-000032005 · Poland · Bytom
BFM Spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: MATERAC EXCLUSIVE, MATERAC GALAXY THERMO OUTLAST, MATERAC JUPITER AIRFLOW OUTLAST, MATERAC MILLENIUM, MATERAC RUBIN.
Devices declared under this manufacturer
- GRAL MATERAC SZAFIR H2/H3 120X200X15
- GRAL MATERAC SZAFIR H2/H3 140X190X15
- GRAL MATERAC SZAFIR H2/H3 200X210X21
- GRAL MATERAC SZAFIR H2/H3 80X200X15
- GRAL MATERAC SZAFIR H2/H3 90X200X15
- MATERAC EXCLUSIVE H1 70X200X24
- MATERAC GALAXY THERMO OUTLAST H 2 70X200X25
- MATERAC JUPITER AIRFLOW OUTLAST H 2 70X200X25
- MATERAC MILLENIUM H1 70X200X21
- MATERAC MILLENIUM H2 70X200X21
- MATERAC RUBIN H 2 70X200X15
- MATERAC SZAFIR H 2 / H 3 70X200X15
Showing 12 of 14 declared devices.
Catalogue references include 5905351910020, 5905351910679, 5905351911607, 5905351912673, 5905351912697, 5905351912796.
European nomenclature codes declared: V0899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| 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 | 14 |
|---|---|
| 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. BFM Spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.