Ontex BV
BE-MF-000003544 · Belgium · Aalst
Ontex BV is registered in the European database on medical devices as a manufacturer, with 1 075 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 075 |
|---|
Most frequent device types declared: Heavy Inco, Light Inco, Underpads.
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 | Ontex BV (BE) · FDA 3010692191 |
| Devices in EUDAMED | 1 075 |
| Country of registration | Belgium |