Omega Pharma International NV
BE-MF-000007210 · Belgium · Ghent
Omega Pharma International NV is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 5 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: Protection.
Devices declared under this manufacturer
- Paranit Fejtetű Megelőző Sampon
- Paranix Champô Proteção Contra Piolhos
- XLS Medical Pro 7
- XLS Medical Pro 7 Capsulas
- XLS Medical Pro 7 Kapseln
- XLS Medical Pro 7 Stick Granulados
Catalogue references include 1000017169 BL, BL28796, CT28086, CT28087, CT28088, CT28089.
European nomenclature codes declared: G0402, V901001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| 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 | 7 |
|---|---|
| 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. Omega Pharma International NV was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
20311GB448260506 | supplemented | 2027-09-21 |