Progenika Biopharma, S.A.
ES-MF-000001005 · Spain · Derio
Progenika Biopharma, S.A. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- A1AT Genotyping Test
- A1AT Genotyping Test Reagents
- ID HPA XT
- ID HPA XT Reagents
- Promonitor CONTROL-ADL
- Promonitor CONTROL-IFX
- Promonitor-ANTI-ADL
- Promonitor-ANTI-ETN
- Promonitor-ANTI-GLM
- Promonitor-ANTI-UTK
- Promonitor-ANTI-VDZ
- Promonitor-ETN
Showing 12 of 21 declared devices.
Catalogue references include 1010220034, 1292320000, 5120230000, 5130230000, 5210230000, 5381530000.
European nomenclature codes declared: W0102080799, W0102080702, W0102080701, W0106010199, W02050192, W0106010499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PROGENIKA BIOPHARMA S.A. (ES) · FDA 3006413195 |
| Devices in EUDAMED | 21 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 21 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 9.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PROGENIKA BIOPHARMA S.A. |
What it holds in Canada
| Licences on record | 15 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| Class 3 devices | 2 |
| First licensed | 2015-01-05 |
Licence types: Test Kit (14), Device Group (1).
Licensed under: PROMONITOR-ANTI-IFX, PROMONITOR-IFX, PROMONITOR-ANTI-ADL, PROMONITOR-ADL, ID CORE XT, PROMONITOR-ANTI-GLM.
North American profile: Both markets. Progenika Biopharma, S.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V13 076212 0030 | reissued | 2031-09-22 |