EU → US Device Access

Unomedical A/S

DK-MF-000002447 · Denmark · Lejre

Unomedical A/S is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb10

Most frequent device types declared: Soft Cannula Sets Diabetic.

Among these devices, 10 are declared sterile.

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 entryUNOMEDICAL A/S (DK) · FDA 8021545
Devices in EUDAMED10
Country of registrationDenmark

Notified body certificates

CertificateStatusExpiry
39124supplemented2027-08-30

Other manufacturers in Denmark

All Denmark manufacturers →