Diagnostica Stago
FR-MF-000017089 · France · Asnières sur Seine
Diagnostica Stago is registered in the European database on medical devices as a manufacturer, with 184 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: C.K. Prest®, STA Compact Max, STA R Max, STA® - Hepato-Prest, STA® - NeoPTimal.
Devices declared under this manufacturer
- Citrate Buffer
- Pool Norm
- STA Compact Max® 2
- STA R Max® 3
- STA® - Fibrinogen 5
- STA® - ImmunoDef VIII
- STA® - ImmunoDef XII
- STA® - Reptilase®
- STA® - SPA +
- STA® - Staclot® APC-R
- STG® - Cal&Fluo
- sthemO Cleaner
Showing 12 of 184 declared devices.
Catalogue references include 00330, 00539, 00674, 00721, 00890, 01234.
European nomenclature codes declared: W0202029099, W0103020702, W0103020701, W0103020101, W0103020606, W0103020999.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DIAGNOSTICA STAGO, INC. (US) · FDA 2245451 |
| Devices in EUDAMED | 184 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 184 |
|---|---|
| Found in the U.S. device database | 52 |
| Share | 28.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DIAGNOSTICA STAGO SAS |
What it holds in Canada
| Licences on record | 30 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 25 |
| Class 3 devices | 5 |
| First licensed | 1999-11-10 |
Licence types: Test Kit (20), System (8), Single Device (2).
Licensed under: STAGO STA SYSTEM, STA COAGULATION SYSTEM, FDP PLASMA, D-D1 TEST (LAYTEX), ASSERACHROM B-TG, ASSERACHROM PF4.
North American profile: Both markets. Diagnostica Stago is registered in both the United States and Canada.