TERUMO EUROPE N.V.
BE-MF-000001434 · Belgium · Leuven
TERUMO EUROPE N.V. is registered in the European database on medical devices as a manufacturer, with 243 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 142 |
|---|---|
| Class IIa | 101 |
Among these devices, 243 are declared sterile, 142 implantable, 7 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TERUMO EUROPE N.V. (BE) · FDA 9681413 |
| Devices in EUDAMED | 243 |
| Country of registration | Belgium |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1594584-1 | supplemented | 2026-12-31 |
3479GB448221124 | issued | 2026-11-30 |
20232GB450221124 | issued | 2026-11-30 |
13090GB450250128 | issued | 2030-01-27 |