EU → US Device Access

3Shape A/S

DK-MF-000001217 · Denmark · Copenhagen K

3Shape A/S is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Among these devices, 8 are declared active.

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 entry3Shape A/S (DK) · FDA 3005940400
Devices in EUDAMED8
Country of registrationDenmark

Other manufacturers in Denmark

All Denmark manufacturers →