EU → US Device Access

Amil Care Italia S.r.l.

IT-MF-000012107 · Italy · Tradate

Amil Care Italia S.r.l. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa24

Among these devices, 12 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 entryAMIL CARE ITALIA S.R.L. (IT) · FDA 3016510805
Devices in EUDAMED24
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
083-00-00-MDRissued2030-10-13

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