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: 77710084 (30s), 77710085 (10s), MOVICOL 13.8g powder for oral solution, MOVICOL Chocolate, MOVICOL Paediatric Chocolate.
Devices declared under this manufacturer
- MOVICOL®
- MOVICOL® Chocolate
- MOVICOL® Paediatric Chocolate
- MOVICOL® Paediatric Plain
- MOVICOL® Plain
- MOVICOL® Ready to Take
- MOVICOL® V
Showing 12 of 15 declared devices.
Catalogue references include 77710013, 77710016, 77710020, 77710023 (50s carton), 77710028, 77710079.
European nomenclature codes declared: G0401.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. Norgine BV was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1676230-1 | issued | 2030-08-28 |