Bio-Novum Sp. z o.o.
PL-MF-000048483 · Poland · Lublin
Bio-Novum Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 95 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: TestiQ.
Devices declared under this manufacturer
- Bile Esculin Agar
- ChromoSys UTI
- Columbia Agar, PH EUR - USP
- Kligler Iron Agar
- Loewenstein-Jensen Medium Base
- MacConkey Agar
- MacConkey Agar No.3
- Mannitol Motility Nitrate (MMN) Medium
- Nutrient Broth
- Sabouraud Dextrose (4%) Chloramphenicol Gentamicin Agar
- Selenite Cystine Broth, USP KIT
- TCBS Agar
Showing 12 of 95 declared devices.
Catalogue references include BNA-100, BNM-0021-500, BNM-0068-500, BNM-0136-100, BNM-0165-500, BNM-0179-100.
European nomenclature codes declared: W0104010101, W0104010104, W0201020201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 95 |
| 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 | 95 |
|---|---|
| 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. Bio-Novum Sp. z o.o. was not found in either the U.S. or the Canadian register.