OrthoXel DAC
IE-MF-000000574 · Ireland · Cork
OrthoXel DAC is registered in the European database on medical devices as a manufacturer, with 786 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 643 |
|---|---|
| Class IIa | 143 |
Most frequent device types declared: INS-1075, INS-1108, INS-1112, INS-1079, INS-1109.
Among these devices, 644 are declared sterile, 643 implantable, 142 reusable, 1 active.
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 | Similar name found — unverified |
|---|---|
| Matched entry | ORTHOXEL (IE) · FDA 3014976005 |
| Devices in EUDAMED | 786 |
| Country of registration | Ireland |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.