EU → US Device Access

SpofaDental a.s.

CZ-MF-000000945 · Czechia · Jicin

SpofaDental a.s. is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa37

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 entrySpofaDental a.s. (CZ) · FDA 3007743883
Devices in EUDAMED37
Country of registrationCzechia

Notified body certificates

CertificateStatusExpiry
44911240240issued2031-05-10

Other manufacturers in Czechia

All Czechia manufacturers →