EU → US Device Access

Eurospital Spa

IT-MF-000028468 · Italy · Trieste

Eurospital Spa is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

other21
Class IIa1

Most frequent device types declared: Eu-Gen FII/FV Type, Eu-Gen MTHFR Dual-Type , Eu-Mag DNA/RNA extraction , Soluzione Fisiologica Eurospital DM.

Among these devices, 1 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 entryEUROSPITAL S.P.A. (IT) · FDA 9615139
Devices in EUDAMED22
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
V13 066267 0039 Rev. 00issued2027-04-03
V13 066267 0039issued2027-04-03

Other manufacturers in Italy

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