Penta Arzneimittel GmbH
DE-MF-000006565 · Germany · Stulln
Penta Arzneimittel GmbH is registered in the European database on medical devices as a manufacturer, with 403 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 367 |
|---|---|
| Class IIa | 36 |
Most frequent device types declared: Eye Drops, Hypertonic Eye Drops, Inhalation Solution, Moisturizing Eye Drops, Nasal Spray.
Among these devices, 403 are declared sterile, 7 reusable.
Devices declared under this manufacturer
- BLUpan® medical UD
- Bepanthenol® Collirio
- Bepanthen® Augentropfen
- Bepanthen® Augentropfen Intense (Muster)
- Bepanthen® Intensive Eye Drops
- Bepanthol® Eye Nemlendirici Göz Damlası Çoklu Doz
- ClariEye®
- EyeMedica® Gereizt + Gerötet Augen-Tropfen SOS
- HYDRO med Green
- Lakroft
- Mivolis Inhalationslösung
- OCUsalin® 5% OSD (Muster)
Showing 12 of 403 declared devices.
Catalogue references include 41080200L, 41083900L, 41106901, 41107800L, 41118500, 41123200.
European nomenclature codes declared: Q02030301, R060203, Q02030299, Q02030399, Q030103, Q02030206.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 403 |
| 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 | 403 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PENTA ARZNEIMITTEL GMBH |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| First licensed | 2017-02-28 |
Licence types: Single Device (7), Device Family (4).
Licensed under: BLUYAL FOR DRY EYES, BLUGEL ULTRA NIGHT, BLUPAN ADVANCED, BLUPAN ALLERGY COMPLETE, BLUGEL ULTRA EYE GEL DROPS, BLUPAN COMPLETE EYE DROPS.
North American profile: Canada only. Penta Arzneimittel GmbH holds a Canadian licence but was not found in the U.S. register.