EU → US Device Access

M.D.L. S.r.l.

IT-MF-000011599 · Italy · Delebio

M.D.L. S.r.l. is registered in the European database on medical devices as a manufacturer, with 624 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa623
other1

Most frequent device types declared: PB2012, PJ0915, PM1815, PN2012, PT17140.

Among these devices, 622 are declared sterile, 1 reusable.

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 entryM.D.L. S.R.L. (IT) · FDA 3004749705
Devices in EUDAMED624
Country of registrationItaly

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