EU → North America Device Access

LUZZANI DENTAL SRL

IT-MF-000011279 · Italy · SENAGO

LUZZANI DENTAL SRL is registered in the European database on medical devices as a manufacturer, with 184 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa184

Most frequent device types declared: AIRMATIC, MULTIFUNCTIONAL SYRINGES.

Among these devices, 184 are declared active.

Devices declared under this manufacturer

Showing 12 of 184 declared devices.

Catalogue references include FNSMMGSG, KVSL6GASG240, MISL6GGASG, PLSBG3GSGD, SBF6SG, SBG6GSG.

European nomenclature codes declared: Z12110199, Q019001.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLUZZANI DENTAL SRL (IT) · FDA 3010057414
Devices in EUDAMED184
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN184
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: United States only. LUZZANI DENTAL SRL is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
IT344114issued2030-07-15

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