EU → US Device Access

AL.CHI.MI.A. S.R.L.

IT-MF-000028901 · Italy · Ponte San Nicolò

AL.CHI.MI.A. S.R.L. is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa34
Class IIb24
Class I2

Among these devices, 47 are declared sterile, 24 implantable.

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 entryAL.CHI.MI.A. SRL (IT) · FDA 3004471819
Devices in EUDAMED60
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.

Other manufacturers in Italy

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