DIAGAST
FR-MF-000012310 · France · Loos
DIAGAST is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- BROMELINE
- BROMELINE PK
- CleanLys
- D-Plates
- DiluentLys
- LISS
- LISS PK
- Mag-Plates
- PAD Buffer
- PAD Buffer 500
- PALERM Papain
- QWALYS
Showing 12 of 14 declared devices.
Catalogue references include 20700, 40100, 40104, 69024, 69301, 69302.
European nomenclature codes declared: W01030399, W0103030307, W0103030306, W0103030399, W0202030102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DIAGAST (FR) · FDA 3006261638 |
| Devices in EUDAMED | 14 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DIAGAST |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 11 |
| First licensed | 2018-06-05 |
Licence types: Device Family (7), Single Device (5), Test Kit (1).
Licensed under: REAGENT RED BLOOD CELLS A1 CELLS / B CELLS, BLOOD GROUPING REAGENTS - ANTI-A, ANTI-B, ANTI, BLOOD GROUPING CONTROL, LISS (LOW-IONIC-STRENGTH SOLUTION), PAPAIN, BLOOD GROUPING REAGENTS - ANTI-C (RH2), ANTI-C.
North American profile: Both markets. DIAGAST is registered in both the United States and Canada.