phenox GmbH
DE-MF-000006524 · Germany · Bochum
phenox GmbH is registered in the European database on medical devices as a manufacturer, with 212 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 210 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: Bifurcation Aneurysm Implant, Neurovascular Flow Diverter, Neurovascular Stent, Neurovascular Treatment Accessories, Thrombectomy Systems.
Among these devices, 212 are declared sterile, 203 implantable.
Devices declared under this manufacturer
- p48 LITE Flow Modulation Device
- p48 LITE HPC Flow Modulation Device
- p48 MW Flow Modulation Device
- p48 MW HPC Flow Modulation Device
- p64 Flow Modulation Device
- p64 MW Flow Modulation Device
- p64 MW HPC Flow Modulation Device
- pCONUS2 Bifurcation Aneurysm Implant
- pCONUS2 HPC Bifurcation Aneurysm Implant
- pEGASUS HPC Stent System
- pEGASUS Stent System
- pORTAL Steerable Hydrophilic Guidewire
Showing 12 of 212 declared devices.
Catalogue references include P48-LT-200-15, P48-MW-200-15, P48-MW-HPC-200-7, P64-300-12, P64-MW-HPC-400-24, P64-MW-HPC-500-30.
European nomenclature codes declared: P070402020102, P0704020202, C010404020402, P0780, C04020201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PHENOX LIMITED (IE) · FDA 3013656790 |
| Devices in EUDAMED | 212 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 212 |
|---|---|
| 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 GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000266808 | supplemented | 2028-12-20 |
1000266807 | supplemented | 2028-12-20 |
1000215968 | issued | 2030-03-02 |
1000190849 | issued | 2029-09-17 |
1000169289 | issued | 2029-03-21 |