3Shape TRIOS A/S
DK-MF-000001218 · Denmark · Copenhagen K
3Shape TRIOS A/S is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 |
|---|
Among these devices, 11 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- 3Shape
- 3shape
Catalogue references include C4.1, C4.2, L1-2, L1P-1, R1.0, R1.1.
European nomenclature codes declared: Q0199, Z12119082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | 3SHAPE TRIOS A/S (DK) · FDA 3009560013 |
| Devices in EUDAMED | 11 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 54.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | 3SHAPE TRIOS A/S |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| First licensed | 2016-01-13 |
Licence types: System (4), Device Family (2), Single Device (2).
Licensed under: TRIOS INTRAORAL SCANNER SYSTEM, TRIOS, TRIOS PATIENT MONITORING, TRIOS 4, TRIOS 5, 3SHAPE F8.
North American profile: Both markets. 3Shape TRIOS A/S is registered in both the United States and Canada.