EU → US Device Access

ACTEON MANUFACTURING

FR-MF-000007556 · France · MERIGNAC

ACTEON MANUFACTURING is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa78
Class I2

Among these devices, 3 are declared sterile, 6 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 registerRegistered with FDA
Matched entryACTEON MANUFACTURING (FR) · FDA 3003677417
Devices in EUDAMED80
Country of registrationFrance

Notified body certificates

CertificateStatusExpiry
40031supplemented2029-10-09
39305supplemented2028-05-24

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