EU → US Device Access

Meditalia Industriale Srl

IT-MF-000032344 · Italy · Lovero

Meditalia Industriale Srl is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb30

Most frequent device types declared: 4911002200, 4310202000, 710000S000, 4911001900, 4911000900.

Among these devices, 30 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 registerNot found in the FDA register
Devices in EUDAMED30
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
MDR 00054-Aissued2029-05-30

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