EU → US Device Access

AGENCINOX SAS

FR-MF-000027551 · France · MONTHOLON

AGENCINOX SAS is registered in the European database on medical devices as a manufacturer, with 85 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa85

Most frequent device types declared: 584, etc.., 627; 626;etc.., 102; 101B, etc.., 2010; 2025; 2050; 2100; 2200; 2300; 2500, etc.., 990PORTE, etc...

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 EUDAMED85
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.

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