Materialise NV
Pelopor dalam perangkat lunak pencetakan 3D dan layanan manufaktur aditif untuk medis, otomotif, dan…
Pelopor dalam perangkat lunak pencetakan 3D dan layanan manufaktur aditif untuk aplikasi medis, otomotif, dan industri.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Leuven, Belgium
- Founded
- 1990
- Website
- materialise.com
- Categories
- Perlengkapan Medis & Kesehatan, Mesin Industri
- Markets
- Belgia, Amerika Serikat, Jerman, Belanda, Jepang
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- lei-active (green), checked 2026-09-07 GLEIF global LEI register (golden copy)
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record
Claimed certifications, not confirmed by us
- 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