Materialise NV

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

Check independently

• Sanctions and watchlists (OpenSanctions)