SEPTODONT
FR-MF-000016992 · France · Saint-Maur-des-Fossés
SEPTODONT is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 65 |
|---|---|
| Class I | 6 |
Among these devices, 58 are declared sterile, 7 implantable.
Devices declared under this manufacturer
- BioRoot RCS
- Biodentine
- Biodentine™ Gun
- Endomethasone Liquid
- Endomethasone N
- Endosolv
- Hemocollagene
- Hydrol
- Racegel
- Racestyptine Solution
- SEPTOJECT XL
- Septoject
Showing 12 of 71 declared devices.
Catalogue references include 333S/0.3 x 12, 333S/0.3 x 21, 333S/0.4 x 21, 333S/0.4 x 25, 334S/0.3 x 09, 335SS/0.3 x 10.
European nomenclature codes declared: A010699, Q01010202, Q01010199, Q010204, Q019003, Q0199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SEPTODONT (FR) · FDA 9610964 |
| Devices in EUDAMED | 71 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 2 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 50.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SEPTODONT |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| Class 3 devices | 4 |
| First licensed | 2002-01-21 |
Licence types: Device Family (4), Single Device (3), Device Group (1), System (1).
Licensed under: SEPTOJECT, SEPTOJECT XL, ULTRA SAFETY PLUS XL NEEDLE, BIODENTINE, ALVEOGYL, BIOROOT RCS.
North American profile: Both markets. SEPTODONT is registered in both the United States and Canada.