URSAPHARM Arzneimittel GmbH
DE-MF-000007748 · Germany · Saarbrücken
URSAPHARM Arzneimittel GmbH is registered in the European database on medical devices as a manufacturer, with 44 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 30 |
|---|---|
| Class IIa | 14 |
Most frequent device types declared: Lubricating eye drops, Lubricating eye ointment, Moistening solution for nasal use, Moistening solution for nasal use (sodium hyaluronate and dexpanthenol, Salt solution for nasal use.
Among these devices, 39 are declared sterile.
Devices declared under this manufacturer
- EvoTears
- HYLO FRESH
- HYLO LIPID
- HYLO NIGHT
- HYLO-FRESH
- POSIFORLID ocní maska
- VitA Nuit
- VitA POS
- hysan CARE
- hysan Hyaluronspray
- hysan Hypertonic Nasal Spray
- hysan aerozol do nosa
Showing 12 of 44 declared devices.
Catalogue references include 55.0825, 55.1368, 55.1411, 55.1823, 55.2536, 55.2677.
European nomenclature codes declared: Q02030399, Q02030206, Q030103, Q02030301, M9001, Q0299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 44 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 44 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | URSAPHARM ARZNEIMITTEL GMBH |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| First licensed | 2012-07-10 |
Licence types: Device Family (3), Single Device (3).
Licensed under: HYCOSAN EXTRA, SOLUTION FOR OCULAR USE, HYCOSAN, SOLUTION FOR OCULAR USE, VITA-POS, EYE OINTMENT FOR OCULAR USE, HYLO-PROTECT, SOLUTION FOR OCULAR USE, HYCOSAN LIGHT, SOLUTION FOR OCULAR USE, HYCOSAN PROTECT FORTE.
North American profile: Canada only. URSAPHARM Arzneimittel GmbH holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1010771-1 | supplemented | 2029-12-12 |