EU → US Device Access

ITENA CLINICAL

FR-MF-000011957 · France · Paris

ITENA CLINICAL is registered in the European database on medical devices as a manufacturer, with 214 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa209
Class IIb5

Among these devices, 103 are declared implantable, 49 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 registerSimilar name found — unverified
Matched entryItena Clinical Villepinte (FR) · FDA 3013557697
Devices in EUDAMED214
Country of registrationFrance
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in France

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