"Biofaktor" Sp. z o. o.
PL-MF-000027226 · Poland · Gorzów Wielkopolski
"Biofaktor" Sp. z o. o. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class IIa | 5 |
Most frequent device types declared: Nasal spray, Rectal suppositories, Vaginal globules.
Devices declared under this manufacturer
- FLORAKCID HA 10 mg
- Hyalotim
- Hyalufil
- INTIVA Dual Care
- INTIVA HYA Comfort
- INTIVA Lacti Balance
- Intivag
- Rectinelle
- Rhinaqua Plus
Catalogue references include 1/2024, 2/2025, 3/2026, 4/2026, GA, GH.
European nomenclature codes declared: U0803, G05, Q030103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| 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 | 4 |
|---|---|
| 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. "Biofaktor" Sp. z o. o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023871-1 | supplemented | 2031-02-05 |