EU → US Device Access

DEKO MedTech Oy

FI-MF-000021251 · Finland · Naarajärvi

DEKO MedTech Oy is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Most frequent device types declared: Deko 190, Deko 2000, DEKO D32, DEKO 2000, DEKO 25.

Among these devices, 9 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 EUDAMED13
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
CR-03-1035-840-24 (01)supplemented2028-05-30

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