EU → North America Device Access

Unigroup ApS

DK-MF-000009459 · Denmark · Lyngby

Unigroup ApS is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa14

Most frequent device types declared: Keratolytic.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include 101035, 101039, 101230.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
Country of registrationDenmark

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

Device-level evidence

Devices with a numeric GTIN14
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. Unigroup ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

All Denmark manufacturers →