EU → North America 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: BUSTO IPERESTENSORE A 3 PUNTI, CAMICE MONOUSO IN TNT RINFORZATO NON STERILE 40gr/mq, CARROZZINA STANDARD AD AUTOSPINTA IN ACCIAO CON ESTRAZIONE RAPIDA CSRG, CUSCINI ANTIDECUBITO PER LORDOSI-CLC2406, GUANTI MONOUSO IN NITIRLE NERI SENZA POLVERE DM- DPI III CAT..

Devices declared under this manufacturer

Showing 12 of 124 declared devices.

Catalogue references include ADE003, CCRT2, CK146, CSRG008/ER, ITA 35, PE008.

European nomenclature codes declared: T01020299, T0205, Y122106, T04010103, T020499, Y060399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED124
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN124
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. I.T.A.L. S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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