EU → North America Device Access

XO CARE A/S

DK-MF-000003605 · Denmark · Hørsholm

XO CARE A/S is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa4
Class IIb1

Most frequent device types declared: CF-100, XO FLEX, XO FLOW, XO ODONTOSURGE 4.

Among these devices, 1 are declared reusable, 5 active.

Devices declared under this manufacturer

Catalogue references include CF-100, CF-200, OSU430.

European nomenclature codes declared: Q0199, Q010399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationDenmark

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

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. XO CARE A/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

All Denmark manufacturers →