EU → US Device Access

I.T.A.L. S.r.l.

IT-MF-000039832 · Italy · FRATTAMAGGIORE

I.T.A.L. S.r.l. is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa124

Most frequent device types declared: GUANTI MONOUSO IN NITRILE SENZA POLVERE DM- DPI CAT.III, CAMICE MONOUSO IN TNT RINFORZATO NON STERILE 40gr/mq, GUANTI MONOUSO IN NITIRLE NERI SENZA POLVERE DM- DPI III CAT., GUANTI MONOUSO IN VINILE TRASPARENTE SENZA POLVERE DM- DPI CAT.III, GUANTI MONOUSO IN NITRILE LUNGO SENZA POLVERE BLU DM- DPI CAT.III.

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 EUDAMED124
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.

Other manufacturers in Italy

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