Laboratorios Grifols S.A.
ES-MF-000000767 · Spain · Parets del Vallès
Laboratorios Grifols S.A. is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 26 |
|---|
Most frequent device types declared: 100 mL Eur.Sur, 100 ml, Eur.Sur.
Among these devices, 26 are declared sterile, 6 active.
Devices declared under this manufacturer
- Agua para irrigación Grifols
- Bags for Gri-fill System: Gri-Bag
- Bolsas para Sistema Gri-fill: Gri-Bag
- Eau pour irrigation Grifols
- GRI-FILL 2 WAYS SET
- GRI-FILL 6 TO 1 SET
- GRI-FILL PERISTALTIC SET
- Glicina al 1,5% Grifols
- Glycocolle 1,5% Grifols
- Salina fisiológica para irrigación Grifols
- Sérum physiologique pour irrigation Grifols
- Vacuflasc
Showing 12 of 26 declared devices.
Catalogue references include 725060, 725061, 725174, 735019, 735202, 735256.
European nomenclature codes declared: A080299, U0380, A0704, A0601010102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LABORATORIOS GRIFOLS, S.A. (ES) · FDA 3002807257 |
| Devices in EUDAMED | 26 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LABORATORIOS GRIFOLS S.A. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2007-11-01 |
Licence types: Device Group Family (1).
Licensed under: BAGS FOR GRI-FILL SYSTEM.
North American profile: Both markets. Laboratorios Grifols S.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023 CR 0002 | issued | 2028-05-31 |
2023 CR 0002 | issued | 2028-05-31 |