GAMIDA TECH

Gamida Tech produces medical devices primarily used in medical imaging or radiation therapy. Their portfolio includes the SunChip 2 (available as a standalone device or as part of an open set), the SunChip1 open set, and the FlowTherm star support mast. These devices are likely designed for positioning or calibration purposes, such as aligning equipment like linear accelerators.

Gamida Tech is based in France, as indicated by its country of origin. The company’s headquarters or primary operational location is therefore within France.

Gamida Tech’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This ensures compliance with EU regulatory requirements for transparency and traceability.

Gamida Tech’s devices fall under Class I and Class IIb classifications under EU medical device regulations. The classification determines the regulatory pathway and level of scrutiny required for market placement, with Class IIb devices typically requiring additional conformity assessments due to their higher risk.