EU → North America Device Access

Villa Manus Oy

FI-MF-000007871 · Finland · Vantaa

Villa Manus Oy is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa61

Most frequent device types declared: 10136/N5, 10152/N5, 10152/N8, 10253/N5, 10263/N5.

Devices declared under this manufacturer

Showing 12 of 61 declared devices.

Catalogue references include 10136/N5, 10152/N5, 10152/N8, 10218, 10222E, 10253.

European nomenclature codes declared: Y060699, Y2199, Z129099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED61
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 GTIN61
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: Neither register. Villa Manus Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

All Finland manufacturers →