EU → North America 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: cotyle XLFIT, cupule XLMOB sans ciment, insert XLMOB PE réticulé, tige KHEOS à cimenter, tige THELIOS HAP.

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

Devices declared under this manufacturer

Showing 12 of 330 declared devices.

Catalogue references include 11-01-08, 11-03-07, 11-06-32, 11-12-13, 11-12-21, 11-13-15.

European nomenclature codes declared: P090804010201, P0908030502, P0908030601, P090804010101, P090804050201, P090803050102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED330
Country of registrationFrance

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

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. PROTHEOS INDUSTRIE was not found in either the U.S. or the Canadian register.

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

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