EU → US Device Access

Cerenion Oy

FI-MF-000012993 · Finland · Oulu

Cerenion Oy is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb4
Class IIa1

Most frequent device types declared: 1.0.0.0.

Among these devices, 4 are declared active.

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 EUDAMED5
Country of registrationFinland
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
FI23/00000060supplemented2027-12-27
FI23/00000060reissued2030-05-04

Other manufacturers in Finland

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