EU → US Device Access

Delfin Technologies Oy

FI-MF-000023804 · Finland · KUOPIO

Delfin Technologies Oy is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: ELM1, SFM1, D-3, MDC2, MDL.

Among these devices, 5 are declared active, 6 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 entryDELFIN TECHNOLOGIES LTD (FI) · FDA 3004896338
Devices in EUDAMED6
Country of registrationFinland

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