EU → North America Device Access

Orthos XXI, Unipessoal Lda

PT-MF-000002787 · Portugal · Briteiros Sta Leocádia

Orthos XXI, Unipessoal Lda is registered in the European database on medical devices as a manufacturer, with 1 028 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 028

Most frequent device types declared: Andalus, Care Seat, Celta, Euphoria, Harmony.

Devices declared under this manufacturer

Showing 12 of 1 028 declared devices.

Catalogue references include 51CDCE2NO37EM, 51CDIN2FE46RR, 51CDSI2NO43ED, 55CM3HABSTD, 55MQNEBO, 58CMMYELRA.

European nomenclature codes declared: Y122106, Y122103, V08030102, Y12030601, V08060101, Y122406.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 028
Country of registrationPortugal

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN1 028
Found in the U.S. device database0
Share0.0 %

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: Neither register. Orthos XXI, Unipessoal Lda was not found in either the U.S. or the Canadian register.

Other manufacturers in Portugal

All Portugal manufacturers →