S.B.M. SAS
FR-MF-000000214 · France · LOURDES
S.B.M. SAS is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 123 |
|---|---|
| Class I | 1 |
Most frequent device types declared: Aiming device, Automatic suture passer & associated needles, Depth gauge, Drill guide, Guide pin introducer.
Among these devices, 1 are declared sterile, 1 implantable, 97 reusable, 17 with a measuring function.
Devices declared under this manufacturer
- CROSS lig®
- ComposiTCP
- FIXIT® / ecoFIX®
- FIXIT® Knotless
- GlenoTech®
- LIGAFIX®
- LIGAFIX® / PULLUP®
- MENIX®
- OTIS-C-PLUS®
- OTIS-F®
- OTIS®
- ecoPass®
Showing 12 of 124 declared devices.
Catalogue references include ANS9005461, EPA9000303, EVO9069428, EVO9069438, LIG9000211, LIG9014300-05.
European nomenclature codes declared: L091099, S0199, L090999, P090199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 124 |
| 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 | 124 |
|---|---|
| Found in the U.S. device database | 103 |
| Share | 83.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | S.B.M. SAS |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 3 |
| First licensed | 2018-03-07 |
Licence types: Device Family (2), Device Group Family (1).
Licensed under: COMPOSITCP 60 INTERFERENCE SCREW, COMPOSITCP 30 INTERFERENCE SCREW, COMPOSITCP DOUBLE LOADED SUTURE ANCHOR.
North American profile: Canada only. S.B.M. SAS holds a Canadian licence but was not found in the U.S. register.