EU → US Device Access

AQUATOOLS

FR-MF-000028808 · France · Paris

AQUATOOLS is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa92

Most frequent device types declared: FILTRAY, FILTRAY , FILTRAY Compact.

Among these devices, 41 are declared sterile.

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 entryAQUA-TOOLS (FR) · FDA 3014640782
Devices in EUDAMED92
Country of registrationFrance

Notified body certificates

CertificateStatusExpiry
40035supplemented2028-02-01
39236supplemented2028-02-01

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