EU → US Device Access

TECNIMED s.r.l.

IT-MF-000007598 · Italy · Vedano Olona (VA)

TECNIMED s.r.l. is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa29

Among these devices, 29 are declared active, 11 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 entryTECNIMED S.R.L. (IT) · FDA 9615140
Devices in EUDAMED29
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
016/MDRsupplemented2026-11-08

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