EU → US Device Access

AQ Solutions GmbH

DE-MF-000005306 · Germany · Köln

AQ Solutions GmbH is registered in the European database on medical devices as a manufacturer, with 119 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa119

Among these devices, 119 are declared reusable.

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 entryAQ SOLUTIONS GMBH (DE) · FDA 3015648612
Devices in EUDAMED119
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
7510GB448251215issued2030-11-11

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