EU → North America Device Access

Sakura Italia Srl

IT-MF-000009937 · Italy · Lonato del Garda (BS)

Sakura Italia Srl is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13
Class IIb2

Most frequent device types declared: ALUNEB IPER NASAL SPRAY, ALUNEB NASAL GEL, ALUNEB NASAL SPRAY, CICASILVER OINTMENT, CICASILVER SPRAY.

Devices declared under this manufacturer

Showing 12 of 15 declared devices.

Catalogue references include SK012501, SK013210, SK013400, SK013400ES, SK015501, SK016200.

European nomenclature codes declared: Q030199, M9099, U0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
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 GTIN15
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. Sakura Italia Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →