EU → US Device Access

EMBODY

FR-MF-000016219 · France · PARIS

EMBODY is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

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 entryEmbody, Inc. (US) · FDA 3015543569
Devices in EUDAMED5
Country of registrationFrance

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