TEKNIMED SAS
FR-MF-000001224 · France · Vic-en-Bigorre
TEKNIMED SAS is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 84 |
|---|---|
| Class IIb | 8 |
Most frequent device types declared: Bowl & Spatula, Cases and Trays, High Viscosity Injection System, Mixing and Injection System for Bone Cement, Mixing and injection system for bone cement.
Among these devices, 30 are declared sterile, 8 implantable, 61 reusable.
Devices declared under this manufacturer
- ACL Implant Instrumentation Case
- Drill Ø8,5mm
- Drill Ø9,5mm
- Max V cement mixing system
- Mini-Malax adapted to High Viscosity Injection System
- Reamer Ø10mm
- Reamer Ø11mm
- Reamer Ø6,5mm
- Screwdriver TLS
- Tap Ø6.5mm
- Trial Plug Ø12mm
- Trial Plug Ø16mm
Showing 12 of 92 declared devices.
Catalogue references include 10001157, T060413B, T0672395, T0672765, T067280, T067291.
European nomenclature codes declared: L091099, P099002, L0999, H0102010299, A019011, L098003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TEKNIMED SAS (FR) · FDA 9615788 |
| Devices in EUDAMED | 92 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 92 |
|---|---|
| Found in the U.S. device database | 34 |
| Share | 37.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TEKNIMED SAS |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 1 |
| First licensed | 2022-12-08 |
Licence types: Device Family (2), Single Device (1).
Licensed under: F20 RADIOPAQUE BONE CEMENT, S5M - MIXING & INJECTION SYSTEM FOR BONE CEMEN, MIXING & INJECTION SYSTEM FOR BONE CEMENT PURE.
North American profile: Both markets. TEKNIMED SAS is registered in both the United States and Canada.