EU → US Device Access

EUROSETS S.R.L.

IT-MF-000023171 · Italy · Medolla

EUROSETS S.R.L. is registered in the European database on medical devices as a manufacturer, with 215 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa213
Class IIb2

Most frequent device types declared: EUDSS.

Among these devices, 172 are declared sterile, 2 reusable, 2 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 entryEurosets s.r.l. (IT) · FDA 3003752502
Devices in EUDAMED215
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
G15 024169 0060supplemented2027-09-29

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