EU → US Device Access

Mectalent Oy

FI-MF-000012330 · Finland · Oulu

Mectalent Oy is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb11
Class IIa3

Most frequent device types declared: JR-010, JR-022, JR-001, JR-020, JR-003.

Among these devices, 11 are declared implantable, 2 reusable.

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 entryMECTALENT LTD. (FI) · FDA 3013156185
Devices in EUDAMED14
Country of registrationFinland

Other manufacturers in Finland

All Finland manufacturers →