EU → US Device Access

PROTHEOS INDUSTRIE

FR-MF-000000150 · France · COURCELLES LES MONTBÉLIARD

PROTHEOS INDUSTRIE is registered in the European database on medical devices as a manufacturer, with 330 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I320
Class IIb10

Most frequent device types declared: tige THELIOS HAP - DMR 11-12/22-00 (B??), tige THELIOS HAP, tige KHEOS à cimenter , cotyle XLFIT, cotyle XLFIT sans ciment - DMR 15-03-00-00 (B??).

Among these devices, 330 are declared sterile, 330 implantable.

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 EUDAMED330
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
39978issued2029-08-27
39976issued2029-08-27
39444issued2028-10-22
39412issued2027-10-13
39411issued2028-09-20
39170issued2027-10-13
39169issued2027-10-13

Other manufacturers in France

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