EU → North America 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, Closing instrument, Drilling instrument, Gauging instrument, Gripping instrument.

Among these devices, 18 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include 14 33 31, 14 33 78, 14 33 78B, 14 33 81, 14 33 86, 14 39 79.

European nomenclature codes declared: L0999.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED23
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN23
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. SACIMEX was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2026 PR 0068issued2031-01-13

Other manufacturers in France

All France manufacturers →