Materialise NV
Pioneer in 3D printing software and additive manufacturing services for medical, automotive and i…
Pioneer in 3D printing software and additive manufacturing services for medical, automotive and industrial applications.
- Type
- Manufacturer
- Location
- Leuven, Belgium
- Founded
- 1990
- Website
- materialise.com
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Belgium, United States, Germany, Netherlands, Japan
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission