EU → US Device Access

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 IIa84
Class IIb8

Most frequent device types declared: Reusable Surgical Instruments, Suture – tendons and ligaments reintegration, Mixing and injection system for bone cement, Vertebroplasty Needles, Cases and Trays .

Among these devices, 30 are declared sterile, 8 implantable, 61 reusable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTEKNIMED SAS (FR) · FDA 9615788
Devices in EUDAMED92
Country of registrationFrance

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