EU → US Device Access

KaliDiv

FR-MF-000047430 · France · AVRILLE

KaliDiv is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other24

Most frequent device types declared: CQI KD-Col/PM/Susp, CQI KD-TraceColor/Part, KD-Color GE, CQI KD-TraceColor/PartInd, CQI KD-Ag/P. falciparum.

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 registerNot found in the FDA register
Devices in EUDAMED24
Country of registrationFrance
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in France

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