EU → US Device Access

HASA OPTIX

BE-MF-000028219 · Belgium · Brussels

HASA OPTIX is registered in the European database on medical devices as a manufacturer, with 2 581 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa2 567
Class I13
Class IIb1

Most frequent device types declared: 551151, 651090, 551139, 551098, 551004.

Among these devices, 1 928 are declared sterile, 1 active, 40 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 entryHASA OPTIX (BE) · FDA 3017857440
Devices in EUDAMED2 581
Country of registrationBelgium

Other manufacturers in Belgium

All Belgium manufacturers →