phenox Ltd
IE-MF-000011333 · Ireland · Galway City
phenox Ltd is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 8 |
|---|
Most frequent device types declared: PNOV-21-160, pRESET Thrombectomy Device 4mm x 20mm, pRESET LITE Thrombectomy Device 3mmx20mm, pRESET LITE Thrombectomy Device 4mmx20mm, pRESET Thrombectomy Device 5mmx40mm.
Among these devices, 8 are declared sterile.
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 | PHENOX LIMITED (IE) · FDA 3013656790 |
| Devices in EUDAMED | 8 |
| Country of registration | Ireland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2245542TD01 | issued | 2029-02-01 |
2245542CE01 | issued | 2029-02-01 |