EU → US Device Access

LO.LI. PHARMA S.r.l.

IT-MF-000023734 · Italy · Roma

LO.LI. PHARMA S.r.l. is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb77
Class IIa1

Most frequent device types declared: Ovulo Vaginale / Vaginal Capsul, MONOGIN OVULI VAGINALI, BRONCOSITOL, MONOGIN GEL, EUMASTOS GEL.

Among these devices, 8 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 EUDAMED78
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
IT339826issued2029-04-15
EPT 0477.MDR.23/5060.3reissued2027-08-03
EPT 0477.MDR.23/5059.5reissued2027-08-03
EPT 0477.MDR.23/5054.1reissued2027-08-03
EPT 0477.MDR.22/5003.3reissued2027-08-03
EPT 0477.MDR.22/4914.2reissued2027-08-03

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