Agfa-Gevaert NV
Agfa は、ヘルスケア、グラフィック アートなどのイメージング テクノロジーと IT ソリューションの世界的リーダーです。
Agfa は、ヘルスケア、グラフィック アート、特殊材料向けのイメージング テクノロジーおよび IT ソリューションの世界的リーダーです。 Mortsel 本社は、デジタル X 線検出器、マンモグラフィー システム、CT スキャナー、放射線科 IT ソフトウェア (XERO Viewer)、およびインクジェット印刷メディアを製造しています。製品は、100 か国以上の病院、画像診断センター、商業印刷会社に販売されています。アグファの特殊製品部門は、政府機関および産業印刷向けに特殊フィルムとセキュリティ用紙を製造しています。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Mortsel, Belgium
- Founded
- 1867
- Website
- agfa.com
- Categories
- 医療およびヘルスケア用品, 包装および印刷用品
- Markets
- アメリカ合衆国, ドイツ, 日本, イギリス, フランス
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