EU → North America Device Access

Dial medicali srl

IT-MF-000031598 · Italy · Cinisello Balsamo

Dial medicali srl is registered in the European database on medical devices as a manufacturer, with 876 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa875
Class IIb1

Among these devices, 332 are declared sterile, 1 implantable.

Devices declared under this manufacturer

Showing 12 of 876 declared devices.

Catalogue references include 02-12000P-S, 03-600015, 04-1100, 04-40140, 04-40180, 05-204459.

European nomenclature codes declared: P0912040101, P0912040102, P09120499, P09120301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED876
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 GTIN876
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. Dial medicali srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030138-00issued2030-07-14

Other manufacturers in Italy

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