EU → US Device Access

F.L. Medical s.r.l. Unipersonale

IT-MF-000013918 · Italy · Torreglia (PD)

F.L. Medical s.r.l. Unipersonale is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other17

Most frequent device types declared: 2115005, 21151, 2115001, 2115003, 21152.

Among these devices, 13 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 registerRegistered with FDA
Matched entryF.L. MEDICAL S.R.L. UNIPERSONALE (IT) · FDA 3009520931
Devices in EUDAMED17
Country of registrationItaly

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