EU → North America Device Access

GENERAL TOPICS SRL

IT-MF-000031008 · Italy · Salò (BS)

GENERAL TOPICS SRL is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I4
Class IIa34
Class IIb1

Most frequent device types declared: ENERPEEL GA-30 20 AMPOLLE, ENERPEEL GA-70 5 AMPOLLE, ENERPEEL HANDS 20 AMPOLLE, ENERPEEL HANDS 5 AMPOLLE, ENERPEEL JR 20 AMPOLLE.

Devices declared under this manufacturer

Showing 12 of 39 declared devices.

Catalogue references include E4, P-GA-30-20, P-HS-5-N, P-JR-20, P-PA-5-N, P-SA-15-20.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED39
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. GENERAL TOPICS SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →