EU → US Device Access

Aeffe Farmaceutici S.r.l.

IT-MF-000028925 · Italy · GORGONZOLA (MI)

Aeffe Farmaceutici S.r.l. is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa26
Class IIb6
Class I1

Most frequent device types declared: Microclismi con glicerolo, camomilla e malva, Supposte di glicerolo.

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 EUDAMED33
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
IT347304issued2030-11-16

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