EU → US Device Access

S.I.I.T. srl

IT-MF-000022188 · Italy · Trezzano sul Naviglio (Milan)

S.I.I.T. srl is registered in the European database on medical devices as a manufacturer, with 397 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa392
Class IIb5

Most frequent device types declared: GC17B, GC04M2 (6,65 g + excipients), GC04A1 (5,068 g with excipients), GC09, GC03.

Among these devices, 3 are declared active.

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 EUDAMED397
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
065-00-03-MDRsupplemented2029-11-20

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