mediCAD Hectec GmbH
DE-MF-000006987 · Germany · Altdorf/Landshut
mediCAD Hectec GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: Medical Software.
Among these devices, 5 are declared active, 3 with a measuring function.
Devices declared under this manufacturer
- mediCAD®
- mediCAD® InsightOR
- mediCAD® MR
- mediCAD® OR
- mediCAD® Web
Catalogue references include med3d - 1101mr-p00, med3d - 1101mr-p01, med3d-1101mr-p00, medc-101, medc-web-1503, medor-1100.
European nomenclature codes declared: Z12139092, Z11039082,Z119082,Z12021182.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | mediCAD HECTEC GMBH (DE) · FDA 3011221522 |
| Devices in EUDAMED | 6 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 33.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDICAD HECTEC GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2015-08-11 |
Licence types: Device Family (1).
Licensed under: MEDICAD.
North American profile: Both markets. mediCAD Hectec GmbH is registered in both the United States and Canada.