EU → US Device Access

Eurosirel Spa

IT-MF-000005982 · Italy · Cusago

Eurosirel Spa is registered in the European database on medical devices as a manufacturer, with 777 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa691
Class I83
other2
Class IIb1

Most frequent device types declared: CMS, CSS, CCS, GIS, CTS.

Among these devices, 57 are declared sterile.

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 registerSimilar name found — unverified
Matched entryEUROSIREL S.P.A (IT) · FDA 3015892095
Devices in EUDAMED777
Country of registrationItaly
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
CVD005826issued2030-08-06
CSQ0031250126supplemented2030-08-06
293/MDRissued2031-06-11

Other manufacturers in Italy

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