EU → US Device Access

SOPRO

FR-MF-000000833 · France · La Ciotat

SOPRO is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa71

Most frequent device types declared: 700342L, 990215, S_802_0001., S_702_0001, S_C50_0001.

Among these devices, 31 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 registerRegistered with FDA
Matched entrySOPRO (FR) · FDA 9615782
Devices in EUDAMED71
Country of registrationFrance

Notified body certificates

CertificateStatusExpiry
39219restricted2027-12-26

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