EU → US Device Access

FISIOLINE SRL

IT-MF-000027924 · Italy · VERDUNO

FISIOLINE SRL is registered in the European database on medical devices as a manufacturer, with 157 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb146
Class IIa11

Most frequent device types declared: LUMIX C.P.S., LUMIX CPS, LUMIX CW, LUMIX PLUS, LUMIX SURGERY DENTAL.

Among these devices, 149 are declared 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 registerSimilar name found — unverified
Matched entryFISIOLINE S.R.L. (IT) · FDA 3004027973
Devices in EUDAMED157
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.

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