Agfa-Gevaert NV
Agfa is a global leader in imaging technology and IT solutions for healthcare, graphic arts, and…
Agfa is a global leader in imaging technology and IT solutions for healthcare, graphic arts, and specialty materials. The Mortsel headquarters manufactures digital X-ray detectors, mammography systems, CT scanners, radiology IT software (XERO Viewer), and inkjet printing media. Products are distributed to hospitals, diagnostic imaging centres, and commercial printers in 100+ countries. Agfa's Specialty Products division produces specialty films and security papers for government and industrial printing.
- Type
- Manufacturer
- Location
- Mortsel, Belgium
- Founded
- 1867
- Website
- agfa.com
- Categories
- Medical & Healthcare Supplies, Packaging & Printing Supplies
- Markets
- United States, Germany, Japan, United Kingdom, France
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 2026-08-23 GLEIF global LEI register (golden copy)
- aeo-certified (green), checked 2026-08-16 EU AEO register (European Commission)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- AEO, Authorised Economic Operator EU AEO database
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)
- Paper and printed products imported into the EU fall under the Deforestation Regulation (EUDR) due-diligence regime. European Commission (EUDR)