EU → US Device Access

CODAN Medical ApS

DK-MF-000001269 · Denmark · Roedby

CODAN Medical ApS is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa86

Most frequent device types declared: 62.1002, 62.1256.

Among these devices, 50 are declared sterile, 86 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 entryCODAN MEDICAL APS. (DK) · FDA 8021538
Devices in EUDAMED86
Country of registrationDenmark

Other manufacturers in Denmark

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