Tornier SAS
FR-MF-000011808 · France · Montbonnot-Saint-Martin
Tornier SAS is registered in the European database on medical devices as a manufacturer, with 134 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 134 |
|---|
Most frequent device types declared: 08858251006896UV, 08858251027970VD, 08858251027991VM, 08858251027998W3, 08858251028003TQ.
Among these devices, 4 are declared sterile, 67 reusable.
Devices declared under this manufacturer
- AEQUALIS REVERSED II
- APSI
- Aequalis® Reversed Fracture
- Aequalis® Reversed II
- Aequalis™ Instrument
- BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION
- Cement Restrictor
- Flex Shoulder System
- Pyrocardan
- RCPI
- Tornier Flex Shoulder System
- Tornier Radial Head System
Showing 12 of 134 declared devices.
Catalogue references include FPYRC13, FRCP16, IRCPR16, MTJ010, MTJ026, MTJ035.
European nomenclature codes declared: L091199, L091102, L091104, P091399, L0999, L0918.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TORNIER, SAS (FR) · FDA 3003902387 |
| Devices in EUDAMED | 134 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 134 |
|---|---|
| Found in the U.S. device database | 113 |
| Share | 84.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TORNIER INC. |
North American profile: Both markets. Tornier SAS is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 005434 0046 | supplemented | 2030-10-01 |