Aflofarm Farmacja Polska Sp. z o.o.
PL-MF-000001809 · Poland · Pabianice
Aflofarm Farmacja Polska Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 23 |
|---|---|
| Class I | 1 |
Most frequent device types declared: 12 pastylek, 15 ml, 18 pastylek, 18 pastylek, 2 pastylki, 24 pastylki.
Devices declared under this manufacturer
- Akustone spray 15 ml/Acustone 15 ml/АкусТон 15 ml PL, HU, CZ, ES, BG
- Calominal
- Desnoran spray do nosa, 30 ml
- Detusan, pastylki
- Dezaftan żel, 8g
- Iladian intima żel, 30 g
- Iladian play & protect żel intymny 50 ml[PL] / Lafemidia® SensiProtec
- Irigasin/Irigaston PL, ES, PT
- Natur-sept gardło pastylki
- Natur-sept kaszel, pastylki
- Natursept med gardło lizaki o smaku wiśniowym/Mivolis Hals Lutscher PL
- Natursept med kaszel lizaki bez cukru
Showing 12 of 24 declared devices.
Catalogue references include WDESS01K, WDETP01K, WILAI01K, WNAKC01K, WNASK01K, WPURI02K.
European nomenclature codes declared: V9017, M9002, Q030103, G0402, Q030199, Q030499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| 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. Aflofarm Farmacja Polska Sp. z o.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0028/2720/2024 | issued | 2027-12-16 |
1434-MDR-025/2024 | issued | 2029-12-11 |
1434-MDR-024/2024 | issued | 2029-12-11 |