EU → US Device Access

WINNCARE FRANCE

FR-MF-000000482 · France · Saint-Paul-Mont-Penit

WINNCARE FRANCE is registered in the European database on medical devices as a manufacturer, with 1 723 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 723

Most frequent device types declared: AXTAIR, X'PRIM, XXL, MPOS, AERYS.

Among these devices, 843 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 registerNot found in the FDA register
Devices in EUDAMED1 723
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
FR26/00000124issued2031-04-14

Other manufacturers in France

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