EU → US Device Access

S.B.M. SAS

FR-MF-000000214 · France · LOURDES

S.B.M. SAS is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa123
Class I1

Most frequent device types declared: Pin, Super elastic guide pin, Screwdriver, Aiming device, Instrument basket.

Among these devices, 1 are declared sterile, 1 implantable, 97 reusable, 17 with a measuring function.

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 EUDAMED124
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.

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