Agfa HealthCare NV

Belgium BE-MF-000000909 Last updated 25 Oct 2026 Part of Agfa Healthcare Corp.

Devices: 2
Registries: EUDAMEDGUDIDFDA
FDA recalls: 0

Catalogue2

Enterprise Imaging Desktops Ref SW_OWN

Class IIa EUDAMEDFDA UDI Active
Enterprise Imaging XERO Viewer Ref SW_OWN

Class IIa EUDAMEDFDA UDI Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Intertek Medical Notified Body AB 2862 1 certificate

28620117074 Expired

Quality management system EU MDR

Issued
25 Aug 2021

Expires
24 Aug 2026

Notified bodies

Intertek Medical Notified Body AB 2862

Information

Country: Belgium(from SRN)
Address: 27, Septestraat, Mortsel, Belgium
Website: www.agfahealthcare.com
Email: [email protected]
Phone: +1(877)777-2432
PRRC contact: Christopher Ball
EUDAMED SRN: BE-MF-000000909
FDA FEI number: 3009238175
DUNS number: 282853795