BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000040114 · Poland · Warsaw
BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- BACTEROMIC Analyzer 2.0
- BACTEROMIC Filling Device 2.0
- BACTEROMIC Interpreter ISW 2.0
- BACTEROMIC Panel UNI 2.0
- BACTEROMIC Panel UNI FAST
- BACTEROMIC Syringe Plug
Catalogue references include BQS-520007, BQS-520008, BQS-520010, BQS-520011, BQS-520012, BQS-520014.
European nomenclature codes declared: W0104080113, W02039099, W0203010192, W02030199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EU-QMS-FI-05877-800024-2026 | issued | 2031-02-20 |