Materialise NV
Active in EUDAMEDBelgiumfrom SRN EUDAMED SRN BE-MF-000000034
- Devices
- 726
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Materialise NV makes
Materialise NV produces custom-made anatomical models and surgical guides for orthopaedic and craniofacial procedures, including bone prostheses and fixation plates. Their portfolio also includes removable dental occlusal splints and CAD/CAM software for medical planning and design. Solutions like the SurgiCase Knee Planner and TruMatch systems support personalised surgical preparation and implant alignment.
These devices are regulated under EU Class I and Class II/IIa classifications, with listings in the EUDAMED registry, FDA’s 510(k) clearance process, and the FDA’s Unique Device Identifier (UDI) database. The company is based in Belgium.
Catalogue
Search and filter all 726 devicesShowing 1-50 of 726
Company details
- EUDAMED SRN
- BE-MF-000000034
- DUNS number
- 373139427
- EU VAT number
- BE0441.131.254
- EUDAMED status
- Active
- EUDAMED registered name
- Materialise NV
- Registered address
- 15, Technologielaan, 3001, Leuven, Belgium
- Website
- www.materialise.com
- Phone
- +32 16 39 66 11
- PRRC contact
- Jan Demol
Frequently asked questions
How many devices does Materialise NV have in the registry?
The registry currently lists 726 devices for Materialise NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Materialise NV's devices?
Among its 50 most recently registered devices, Materialise NV has devices listed in EUDAMED (31 devices) and FDA GUDID (19 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Materialise NV's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Materialise NV's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Materialise NV in the registry?
The most recently registered devices listed for Materialise NV include TruMatch CMF Titanium 3D Printed Plates, Mimics Automatic Algorithms, TRUMATCH SD980.041 and TRUMATCH SD980.042.