EU → US Device Access

Drugs Minerals and Generics Italia S.r.l.

IT-MF-000024945 · Italy · Pomezia

Drugs Minerals and Generics Italia S.r.l. is registered in the European database on medical devices as a manufacturer, with 279 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa174
Class IIb89
Class I16

Most frequent device types declared: Soluzione Otologica, Unguento e Gocce Nasali, Sciroppo Antireflusso, Spray Nasale con D-Pantenolo, Vitamina A ed E, Unguento Barriera Emostatico.

Among these devices, 38 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 EUDAMED279
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
EPT 0477.MDR.26/6093issued2029-04-11
EPT 0477.MDR.25/6038.2reissued2029-04-11
EPT 0477.MDR.25/6035.1reissued2029-04-11
EPT 0477.MDR.24/5448issued2029-04-11
EPT 0477.MDR.24/5447issued2029-04-11
EPT 0477.MDR.24/5446issued2029-04-11
EPT 0477.MDR.24/5445issued2029-04-11
EPT 0477.MDR.24/5444issued2029-04-11

Other manufacturers in Italy

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