EU → US Device Access

Henrotek A/S

DK-MF-000029313 · Denmark · Rødding

Henrotek 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

Most frequent device types declared: Technical aid for disable people, Technical aid for disabled .

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 entryHENROTEK A/S (DK) · FDA 3028012839
Devices in EUDAMED8
Country of registrationDenmark

Other manufacturers in Denmark

All Denmark manufacturers →