EU → US Device Access

Ikerian AG

CH-MF-000014537 · Switzerland · Bern

Ikerian AG is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6
Class IIb1

Most frequent device types declared: OCT Atlas 4.0.0.

Among these devices, 6 are declared active.

Authorised representative in the Union: LI-AR-000000233.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationSwitzerland
⚠️ 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.

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