EU → North America Device Access

RUNNER SRL

IT-MF-000029314 · Italy · CAVEZZO

RUNNER SRL is registered in the European database on medical devices as a manufacturer, with 346 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa346

Among these devices, 346 are declared active.

Devices declared under this manufacturer

Showing 12 of 346 declared devices.

Catalogue references include RUN2011/TJ-PC configurazione P, RUN2011/TJ-PC versione X, RUN2011/TR-PC versione S, RUN7410/TR-PC configurazione G, RUN7411/TJ-PC configurazione E, RUN7411/TJ-PC configurazione H.

European nomenclature codes declared: Z129006, Z129003.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED346
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 GTIN346
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. RUNNER SRL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 1344179 1issued2030-09-28

Other manufacturers in Italy

All Italy manufacturers →