EU → North America 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: 551004, 551098, 551139, 552039NS, 553027NS.

Among these devices, 1 928 are declared sterile, 1 active, 40 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 2 581 declared devices.

Catalogue references include 551004, 551098, 551139, 553027NS, 555018, 556036.

European nomenclature codes declared: Q021102, Q021113, Q021103, Q021104, Q021199, Q021106.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHASA OPTIX (BE) · FDA 3017857440
Devices in EUDAMED2 581
Country of registrationBelgium

Device-level evidence

Devices with a numeric GTIN2 581
Found in the U.S. device database204
Share7.9 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. HASA OPTIX is registered in the United States but was not found in the Canadian register.

Other manufacturers in Belgium

All Belgium manufacturers →