EU → US Device Access

Natus Medical Denmark ApS

DK-MF-000001617 · Denmark · Taastrup

Natus Medical Denmark ApS is registered in the European database on medical devices as a manufacturer, with 358 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa358

Most frequent device types declared: 8-04-16030, 1081 Aurical Aud, MADSEN Astera 2, 8-68-31514, 1085 ICS Impulse System.

Among these devices, 1 are declared sterile, 7 reusable, 286 active, 75 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 entryNatus Medical Denmark ApS (DK) · FDA 9612197
Devices in EUDAMED358
Country of registrationDenmark

Other manufacturers in Denmark

All Denmark manufacturers →