EU → North America Device Access

Asa Dental S.p.A.

IT-MF-000010736 · Italy · Bozzano - Massarosa

Asa Dental S.p.A. is registered in the European database on medical devices as a manufacturer, with 118 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa118

Most frequent device types declared: 3510, Cannule aspirasaliva monouso, Curette, Manico, Martello.

Among these devices, 22 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 118 declared devices.

Catalogue references include 0103-10, 0350-3G, 1355-1, 2900E-BCS15, 3400e-200, 3403-140.

European nomenclature codes declared: Y181806, Q0199, Q019001, S01010101, L159099, L159003.

United States market access

FDA establishment registerRegistered with FDA
Matched entryASA DENTAL S.P.A. (IT) · FDA 8021050
Devices in EUDAMED118
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN118
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. Asa Dental S.p.A. is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030177-00issued2031-03-11
0425-MDR-030166-00issued2030-12-21

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