EU → US Device Access

SACIMEX

FR-MF-000011190 · France · Aix en Provence

SACIMEX is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa23

Most frequent device types declared: Aiming instruments, Screwdrivers, Gripping instrument, Drilling instrument, Traction Table.

Among these devices, 18 are declared 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 EUDAMED23
Country of registrationFrance
⚠️ 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
2026 PR 0068issued2031-01-13

Other manufacturers in France

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