EU → North America Device Access

Dassiet Oy

FI-MF-000016466 · Finland · Espoo

Dassiet Oy is registered in the European database on medical devices as a manufacturer, with 91 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa91

Most frequent device types declared: A001, A002 and A003.

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Showing 12 of 91 declared devices.

Catalogue references include A-THUMB-SH, B1240S, B1580, C1434S, C1480 Black, C1480S Blue.

European nomenclature codes declared: M03050201, M010299, M030599, M03050202, M9002, M030501.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED91
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 GTIN91
Found in the U.S. device database34
Share37.4 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. Dassiet Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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