UNION DENTAL S.A.
ES-MF-000003189 · Spain · TIELMES
UNION DENTAL S.A. is registered in the European database on medical devices as a manufacturer, with 6 195 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 195 |
|---|
Most frequent device types declared: Artificial Teeth.
Among these devices, 2 are declared implantable.
Devices declared under this manufacturer
- ELEDENT
- ELEPHANDENS
- IDODENT
- IDODENTINE
- ODIDENT
- ODILIUX
- ODILUX
- ODIMAX
- ODIPAL
- ORTOLUX TOP
Showing 12 of 6 195 declared devices.
Catalogue references include D113EP13, D3603P, M114AM34I, M114BM56I, M36829I, M3D454S.
European nomenclature codes declared: Q01020601,Q01020602,Q01020603,Q01020605, Q0102050101,Q0102050102,Q0102050199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | UNION DENTAL S.A. (ES) · FDA 3005350578 |
| Devices in EUDAMED | 6 195 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 6 195 |
|---|---|
| Found in the U.S. device database | 3 407 |
| Share | 55.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | UNION DENTAL S.A. |
North American profile: Both markets. UNION DENTAL S.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2025 CR 0043 | supplemented | 2030-02-09 |