EU → North America Device Access

CIZETA SURGICAL S.r.l.

IT-MF-000027906 · Italy · San Lazzaro di Savena (BO)

CIZETA SURGICAL S.r.l. is registered in the European database on medical devices as a manufacturer, with 101 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa97
Class IIb4

Among these devices, 4 are declared implantable, 97 reusable.

Devices declared under this manufacturer

Showing 12 of 101 declared devices.

Catalogue references include 0411C-12, 0411M-12, 0414C-6, 042016-9, 042045-5, 042345-7.

European nomenclature codes declared: P0180, P09120604, P09120403.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED101
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 GTIN101
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. CIZETA SURGICAL S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
029-00-00-MDRissued2028-09-14

Other manufacturers in Italy

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