sebia
FR-MF-000003520 · France · Lisses
sebia is registered in the European database on medical devices as a manufacturer, with 126 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- CAPILLARYS 3 & MC SHUTDOWN RACK (1)
- CAPILLARYS 3 DBS
- CLEAR DILUTION SEGMENTS (90)
- COLORED REFERENCE GUIDES (DM)
- DIALYSIS SYSTEM (24)
- HYDRASHIFT 2/4 isatuximab (40 TESTS)
- HYDRASYS 2 SCAN FOCUSING
- HYDRASYS 9 BENCE JONES ACCESSORIES (SM)
- HYDRASYS CONTAINER (WHITE CAP) 5 L
- HYDRASYS CONTAINER KIT
- HYDRASYS LIPOPROTEIN(E)S ACCESSORIES
- Hb A1c CAPILLARY CALIBRATORS (2)
Showing 12 of 126 declared devices.
Catalogue references include 1202, 1263, 1282, 1391, 1654, 2080.
European nomenclature codes declared: W020105019099, W0599, W01019099, W050301020280, W020105010202, W050301020180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SEBIA (FR) · FDA 8023024 |
| Devices in EUDAMED | 126 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 126 |
|---|---|
| Found in the U.S. device database | 24 |
| Share | 19.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SEBIA |
What it holds in Canada
| Licences on record | 18 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 18 |
| First licensed | 1999-06-08 |
Licence types: System (8), Device Family (4), Test Kit (3), Device Group Family (1).
Licensed under: CAPILLARYS 3 ELECTROPHORESIS SYSTEM, HYDRAGEL PROTEIN K2O, HYDRAGEL HEMOGLOBIN FOR HYDRASYS, HYDRAGEL ACID HEMOGLOBIN FOR HYDRASYS, HYDROGEL HIGH RESOLUTION FOR HYDRASYS, HYDRAGEL BENCE JONES K2O.
North American profile: Both markets. sebia is registered in both the United States and Canada.