EU → US Device Access

ELMAC ELETTRONICA S.R.L.

IT-MF-000029501 · Italy · Tavullia

ELMAC ELETTRONICA S.R.L. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb5

Most frequent device types declared: TRICOPAT, ASAPSMED, ASCAMPOMATS_1NEED_MN_PRO, EVO OMNIA, ASCAMPOMATS_1NEED_MN.

Among these devices, 5 are declared active.

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 entryELMAC ELETTRONICA S.R.L. (IT) · FDA 3016899893
Devices in EUDAMED5
Country of registrationItaly

Other manufacturers in Italy

All Italy manufacturers →