Agfa NV
BE-MF-000000571 · Belgium · Mortsel
Agfa NV is registered in the European database on medical devices as a manufacturer, with 135 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 122 |
|---|---|
| Class IIb | 13 |
Among these devices, 32 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- CP-BU M
- CR MD1.0 CASSETTE ADAPTER
- CR MD1.0 GENERAL SET
- CR MD4.0T GENERAL SET
- CRYSTAL FILM CF-B
- DR 400
- DR 800
- DR FLFS Detector Positioner
- DRYSTAR DT 5 B
- DRYSTAR DT 5.000I B
- Drystar AXYS
- G354
Showing 12 of 135 declared devices.
Catalogue references include 51BN8, 55BK1, 5R3GU, 5YH3E, 5ZGHB, EVHC1.
European nomenclature codes declared: Z130106, Z11060280, Z130101, Z11079085, Z11031101, Z110706.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 135 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 135 |
|---|---|
| Found in the U.S. device database | 51 |
| Share | 37.8 % |
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Agfa NV was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620125060 | supplemented | 2027-05-31 |