EU → North America 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: D-3, ELM1, MDC2, MDL, SFM1.

Among these devices, 5 are declared active, 6 with a measuring function.

Catalogue references include D3001, ELM1001, MDC2001, MDL2001, SFM1001, SWL5001.

European nomenclature codes declared: V0399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDELFIN TECHNOLOGIES LTD (FI) · FDA 3004896338
Devices in EUDAMED6
Country of registrationFinland

Device-level evidence

Devices with a numeric GTIN6
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: United States only. Delfin Technologies Oy is registered in the United States but was not found in the Canadian register.

Other manufacturers in Finland

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