EU → US Device Access

PROMOTAL

FR-MF-000001666 · France · Ernée

PROMOTAL is registered in the European database on medical devices as a manufacturer, with 105 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa105

Most frequent device types declared: DENEO, 118, GMOTIO, IDUOLYS, QUEST.

Among these devices, 58 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 registerSimilar name found — unverified
Matched entryPROMOTAL SASU (FR) · FDA 8023021
Devices in EUDAMED105
Country of registrationFrance
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in France

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