3Shape A/S
DK-MF-000001217 · Denmark · Copenhagen K
3Shape A/S is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- 3Shape
- 3shape
Catalogue references include 88.2, E2, E3, E4, R1.0, R1.1.
European nomenclature codes declared: Z12119082, Q0199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | 3Shape A/S (DK) · FDA 3005940400 |
| Devices in EUDAMED | 8 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 87.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | 3SHAPE A/S |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| First licensed | 2014-04-17 |
Licence types: Single Device (5), Device Family (3).
Licensed under: 3SHAPE DENTAL SYSTEM, 3SHAPE ORTHO SYSTEM, 3SHAPE IMPLANT STUDIO, ANATOMY DESIGN, 3SHAPE ABUTMENT DESIGN, 3SHAPE SPLINT DESIGN.
North American profile: Both markets. 3Shape A/S is registered in both the United States and Canada.