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Agfa HealthCare NV

Manufacturer of medical devices registered in the European database in Mortsel, Belgium.

Registration number (SRN)BE-MF-000000909
RoleManufacturer
StatusActive
CountryBelgium
City2640 Mortsel
AddressSeptestraat, 27 2640 Mortsel
Registered on2021-01-25

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryAGFA HEALTHCARE INC. (CA) · FDA 9680497

Notified body certificates

CertificateStatusExpiryTypeBody
28620117074validexpired 2026-08-24Quality management systemNB 2862

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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