EU → North America 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.

Devices declared under this manufacturer

Catalogue references include 300100, 300200, 300300, Cerenion C-Trend Software Library, Version 1.0.0.0.

European nomenclature codes declared: Z12100392, Z12100302, N01010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationFinland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN4
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Cerenion Oy was not found in either the U.S. or the Canadian register.

Notified body certificates

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

Other manufacturers in Finland

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