Norgine BV
NL-MF-000009565 · Netherlands · Amsterdam
Norgine BV is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 15 |
|---|
Most frequent device types declared: MOVICOL Plain, MOVICOL Paediatric Plain, 77710085 (10s), 77710084 (30s), MOVICOL, powder for oral solution.
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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| Country of registration | Netherlands |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1676230-1 | issued | 2030-08-28 |