EU → North America Device Access

Dispotech srl

IT-MF-000010735 · Italy · GORDONA

Dispotech srl is registered in the European database on medical devices as a manufacturer, with 338 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa338

Among these devices, 182 are declared active.

Devices declared under this manufacturer

Showing 12 of 338 declared devices.

Catalogue references include AP100TARPERFIX, SF1853EUSPITAL2, SF1853PRODONTO, SF1854SIXGISU, SG26SELECT, SG26SIXTUS.

European nomenclature codes declared: M9001, M9099, Q019001, Q019004, T020604, S01020101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED338
Country of registrationItaly

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

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. Dispotech srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITD 1344523 1supplemented2029-07-29

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