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.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | Materialise Sdn Bhd (MY) · FDA 3009555447 |
| Devices in EUDAMED | 112 |
| Country of registration | Belgium |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.