Materialise NV
Пионер в области программного обеспечения для 3D-печати и услуг аддитивного производства для медицины, автомобилестроения и…
Пионер в области программного обеспечения для 3D-печати и услуг аддитивного производства для медицинского, автомобильного и промышленного применения.
- Type
- brand seeking distribution
- Location
- Leuven, Belgium
- Founded
- 1990
- Website
- materialise.com
- Categories
- Медицинские товары и расходники, Промышленные станки и машины
- Markets
- Бельгия, Соединенные Штаты, Германия, Нидерланды, Япония
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 2026-08-30 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
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment