EU → US Device Access

Q-linea AB

SE-MF-000013026 · Sweden · Uppsala

Q-linea AB is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other5

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 entryQ-linea AB (SE) · FDA 3027320620
Devices in EUDAMED5
Country of registrationSweden

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