Agfa-Gevaert NV
Agfa는 의료, 그래픽 아트 및 의료 분야의 이미징 기술 및 IT 솔루션 분야의 글로벌 리더입니다.
Agfa는 의료, 그래픽 아트 및 특수 재료를 위한 이미징 기술 및 IT 솔루션 분야의 글로벌 리더입니다. Mortsel 본사는 디지털 X선 검출기, 유방 조영술 시스템, CT 스캐너, 방사선 IT 소프트웨어(XERO Viewer) 및 잉크젯 인쇄 매체를 제조합니다. 제품은 100개 이상의 국가에 있는 병원, 진단 영상 센터, 상업용 프린터에 배포됩니다. Agfa의 특수 제품 사업부는 정부 및 산업용 인쇄용 특수 필름과 보안 용지를 생산합니다.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Mortsel, Belgium
- Founded
- 1867
- Website
- agfa.com
- Categories
- 의료 및 건강 관리 용품, 포장 및 인쇄 용품
- Markets
- 미국, 독일, 일본, 영국, 프랑스
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