EU → US Device Access

Novo Nordisk A/S

DK-MF-000002222 · Denmark · Bagsværd

Novo Nordisk A/S is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb21
Class IIa8

Among these devices, 2 are declared sterile, 6 active, 21 with a measuring function.

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 entryNOVO NORDISK A/S (DK) · FDA 9681821
Devices in EUDAMED29
Country of registrationDenmark

Other manufacturers in Denmark

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