EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K.
PL-MF-000007178 · Poland · Warszawa
EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K. is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 30 |
|---|---|
| Class IIa | 4 |
Most frequent device types declared: 10 ml, 30 ml.
Devices declared under this manufacturer
- Artelac Ear Drops
- Artelac Otic
- Audispray Dolo
- Auridol
- Ceruprotect
- Doloceril
- Easyear
- Etos Oordruppels
- Kordol
- Lix
- Nollix spray do nosa
- Oritolin spray do gardła
Showing 12 of 34 declared devices.
Catalogue references include 5902020885726.
European nomenclature codes declared: M9002, M9003.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 34 |
| 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 | 33 |
|---|---|
| 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. EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0060/5756/2026 | issued | 2031-05-18 |
TNP/MDR/0054/5756/2026 | supplemented | 2031-05-18 |