EU → US Device Access

Disior Oy

FI-MF-000002448 · Finland · HELSINKI

Disior Oy is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3
Class IIb2

Most frequent device types declared: Bonelogic Neuro, Bonelogic 2, Bonelogic CMF Orbital, Bonelogic 1.0, Bonelogic 2.2.

Among these devices, 5 are declared active, 3 with a measuring function.

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 registerRegistered with FDA
Matched entryDISIOR OY (FI) · FDA 3018064242
Devices in EUDAMED5
Country of registrationFinland

Notified body certificates

CertificateStatusExpiry
FI20/00000020issued2026-05-30

Other manufacturers in Finland

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