Materialise NV
BE-MF-000000034 · Belgium · Leuven
Materialise NV is registered in the European database on medical devices as a manufacturer, with 112 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 66 |
|---|---|
| Class IIb | 46 |
Among these devices, 53 are declared sterile, 46 implantable, 6 active, 6 with a measuring function.
Devices declared under this manufacturer
- Materialise Mimics Enlight CMF
- Materialise Splints
- Materialise Titanium 3D Printed Guides
- Materialise Titanium 3D Printed Plates
- Mimics Cardiac Planner
- SurgiCase Knee Planner
- SurgiCase Shoulder Planner
Showing 12 of 112 declared devices.
Catalogue references include CMF.Ti060D, CMF.Ti074D, CMF.Ti081H, CMFsTi058D, CMFsTi061D, CMFsTi063H.
European nomenclature codes declared: P091399, P09120599, Z119092.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | MATERIALISE N.V. (BE) · FDA 3003998208 |
| Devices in EUDAMED | 112 |
| Country of registration | Belgium |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 112 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 2.7 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | MATERIALISE N.V. |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 12 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| Class 3 devices | 1 |
| First licensed | 2005-12-28 |
Licence types: System (6), Device Family (4), Single Device (2).
Licensed under: ORTHOVIEW DIGITAL IMAGING, PROPLAN CMF GUIDES, PROPLAN CMF SOFTWARE, MATERIALISE PERSONALIZED SOLUTIONS OSTEOTOMY G, MIMICS MEDICAL, TRUMATCH CMF TITANIUM 3D PRINTED IMPLANT SYSTE.