i-SEP
FR-MF-000000363 · France · Nantes
i-SEP is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|
Among these devices, 10 are declared sterile.
Catalogue references include BW1000M1, BW5000M1, LE0000M1, LF0000M1, XJ-13-05, XJ-28-18.
European nomenclature codes declared: B0480.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | I-SEP |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-02-18 |
Licence types: System (1).
Licensed under: SAME BY I-SEP.
North American profile: Canada only. i-SEP holds a Canadian licence but was not found in the U.S. register.