ErgoDenta ApS
DK-MF-000046416 · Denmark · Taastrup
ErgoDenta ApS is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: DENTAL EXPLORER, Plain Mouth Mirror.
Devices declared under this manufacturer
- ErgoDenta
- ErgoDenta ApS
- ErgoSteel Mini
- Front Surface Mouth Mirror No.3, 20mm
Catalogue references include 1001 S, 1503F, 1503P, 1504F, 1504P.
European nomenclature codes declared: L160201, L159003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ERGODENTA APS (DK) · FDA 3043047788 |
| Devices in EUDAMED | 5 |
| Country of registration | Denmark |
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: United States only. ErgoDenta ApS is registered in the United States but was not found in the Canadian register.