EU → North America Device Access

David Health Solutions Oy

FI-MF-000003986 · Finland · Helsinki

David Health Solutions Oy is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa18

Most frequent device types declared: G130, G150, G160, G200, G220.

Among these devices, 18 are declared active, 18 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include 9G16601A, 9G20605C, 9G22506A, 9G26604C, 9G32504D, 9G42604A.

European nomenclature codes declared: Z120602.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDAVID HEALTH SOLUTIONS, LTD. (FI) · FDA 3016018167
Devices in EUDAMED18
Country of registrationFinland

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. David Health Solutions Oy is registered in the United States but was not found in the Canadian register.

Other manufacturers in Finland

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