Agfa-Gevaert NV
Agfa, sağlık hizmetleri, grafik sanatlar ve sektörlere yönelik görüntüleme teknolojisi ve BT çözümlerinde dünya lideridir…
Agfa, sağlık hizmetleri, grafik sanatları ve özel malzemelere yönelik görüntüleme teknolojisi ve BT çözümlerinde dünya lideridir. Mortsel genel merkezi, dijital X-ışını dedektörleri, mamografi sistemleri, CT tarayıcıları, radyoloji BT yazılımı (XERO Viewer) ve mürekkep püskürtmeli baskı ortamı üretmektedir. Ürünler 100'den fazla ülkedeki hastanelere, teşhis görüntüleme merkezlerine ve ticari yazıcılara dağıtılmaktadır. Agfa'nın Özel Ürünler bölümü, kamu ve endüstriyel baskılar için özel filmler ve güvenlik kağıtları üretmektedir.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Mortsel, Belgium
- Founded
- 1867
- Website
- agfa.com
- Categories
- Tıbbi ve Sağlık Malzemeleri, Ambalaj ve Baskı Malzemeleri
- Markets
- Amerika Birleşik Devletleri, Almanya, Japonya, Birleşik Krallık, Fransa
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