EU → US 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.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED101
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

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