orangedental GmbH & Co. KG
DE-MF-000006152 · Germany · Biberach a.d. Riß
orangedental GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Among these devices, 4 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- opt-on 2.7
- opt-on 3.3
- pa-on Einmalspitzen sterilisierbar
- spot-on cordfree
- spot-on nxt
Catalogue references include 04260375690015, 04260375690732, 4260375690091 / lup0499000, 4260375690107 / lup0499100, 4260375690138 / lup0499110, 4260375690718 / lup0499200.
European nomenclature codes declared: Z129004, Z129099, V0399, V92, Q010599.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| 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 | 5 |
|---|---|
| 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. orangedental GmbH & Co. KG was not found in either the U.S. or the Canadian register.