DentalOrganiser Ltd
IE-MF-000043529 · Ireland · Galway
DentalOrganiser Ltd is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: VISIONBUT.MB.
Devices declared under this manufacturer
- VisionButler Lip and Cheek Retractor
Catalogue references include 5391528150359, 5391528150816, 5391528150823, 5391528150830, 5391528150847, 5391528150854.
European nomenclature codes declared: Q01010401.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| Country of registration | Ireland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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. DentalOrganiser Ltd was not found in either the U.S. or the Canadian register.