EU → US Device Access

ArjoHuntleigh AB

SE-MF-000000696 · Sweden · Malmö

ArjoHuntleigh AB is registered in the European database on medical devices as a manufacturer, with 8 654 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8 506
Class IIb148

Most frequent device types declared: AL21000-EU, FA0A011OAAT0, 8X13GY113DCABA, 9X21AE111BFCSA, 120PM000/000.

Among these devices, 7 557 are declared active, 3 800 with a measuring function.

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 entryARJOHUNTLEIGH AB (SE) · FDA 3002806395
Devices in EUDAMED8 654
Country of registrationSweden

Other manufacturers in Sweden

All Sweden manufacturers →