exocad GmbH
DE-MF-000007341 · Germany · Darmstadt
exocad GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 13 |
|---|
Most frequent device types declared: 1.0, 2.1, 2.3, 3.0.
Among these devices, 13 are declared active, 13 with a measuring function.
Devices declared under this manufacturer
- Ceramill Mind DRS
- Ceramill Mind DRS 3.1
- ChairsideCAD
- ChairsideCAD 3.0 Galway
- ChairsideCAD 3.1 Rijeka
- exoplan
- exoplan 3.0 Galway
- exoplan 3.1 Rijeka
- exoplan 3.3 Chemnitz
Showing 12 of 13 declared devices.
Catalogue references include 04260521363039, 04260521363312, 4260521363015, 4260521363022, 4260521363305, 4260521365002.
European nomenclature codes declared: Q01010199, Q010399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EXOCAD GMBH (DE) · FDA 3011521456 |
| Devices in EUDAMED | 13 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| Found in the U.S. device database | 12 |
| Share | 92.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EXOCAD GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2019-09-16 |
Licence types: Device Family (2).
Licensed under: EXOPLAN, CHAIRSIDECAD.
North American profile: Both markets. exocad GmbH is registered in both the United States and Canada.