Candulor AG
CH-MF-000015795 · Switzerland · Glattpark (Opfikon)
Candulor AG is registered in the European database on medical devices as a manufacturer, with 1 434 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 434 |
|---|
Authorised representative in the Union: Candulor Dental GmbH.
Devices declared under this manufacturer
- AESTHETIC Red Polymer 500g F5
- Bonartic TCR Juego de 8 S02+ J3
- Physioset TCR 6er O332+ M4
- Physioset TCR 6er O343+ B3
- Physioset TCR Bouche à 6 S425+ A1
- Physioset TCR Juego de 6 S264+ B4
- Physioset TCR Set of 6 U302+ J2
- Physioset TCR Set of 6 U424+ B3
- Preference 6er O320+ C3
- Preference Bouche à 6 S310+ A3
- Preference Bouche à 6 S350+ C4
- Preference Juego de 6 S450+ D3
Showing 12 of 1 434 declared devices.
Catalogue references include 552379, 552643, 553433, 578266, 578293, 578309.
European nomenclature codes declared: Q010699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CANDULOR, AG (CH) · FDA 1000277456 |
| Devices in EUDAMED | 1 434 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 1 434 |
|---|---|
| Found in the U.S. device database | 1 412 |
| Share | 98.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CANDULOR AG |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| First licensed | 2006-04-11 |
Licence types: Device Family (5), Device Group Family (2), System (2), Single Device (2).
Licensed under: COMPOSITE TEETH, RESIN TEETH, HEAT CURING DENTURE BASE MATERIAL, STAINS FOR RESIN TEETH, COLD CURING DENTURE BASE MATERIAL, ACRYLIC TEETH.
North American profile: Both markets. Candulor AG is registered in both the United States and Canada.