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 LITE Thrombectomy Device 3mmx20mm, pRESET LITE Thrombectomy Device 4mmx20mm, pRESET Thrombectomy Device 4mm x 20mm, pRESET Thrombectomy Device 5mmx40mm.
Among these devices, 8 are declared sterile.
Devices declared under this manufacturer
- pNOVUS 21 Microcatheter
- pRESET LITE Thrombectomy Device
- pRESET Thrombectomy Device
Catalogue references include IE102032011, IE102042001, IE102042011, IE102054001, IE102063001, PNOV-21-150.
European nomenclature codes declared: C010404020401, C0104020205, C0104020202.
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 |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PHENOX LTD |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 4 devices | 1 |
| First licensed | 2022-11-18 |
Licence types: Device Family (1).
Licensed under: PRESET THROMBECTOMY DEVICE.
North American profile: Both markets. phenox Ltd is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2245542TD01 | issued | 2029-02-01 |
2245542CE01 | issued | 2029-02-01 |