Agfa-Gevaert 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

• corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
• debarment-clear (green), checked 2026-08-03 OpenSanctions
• registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
• sanctions-clear (green), checked 2026-08-03 OpenSanctions
• domain-registered (green), checked 2026-08-03 Domain registry record
• lei-active (green), checked 2026-09-07 GLEIF global LEI register (golden copy)
• aeo-certified (green), checked 2026-08-30 EU AEO register (European Commission)
• registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record

Claimed certifications, not confirmed by us

• ISO 9001, Quality Management IAF CertSearch
• ISO 13485, Medical Devices Quality 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)
• If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)
• 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)