EU → North America Device Access

MelaMedic ApS

DK-MF-000042515 · Denmark · Aars

MelaMedic ApS is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Most frequent device types declared: MM-011.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include Bern III, MM-001, MM-004, MM-037, MM-051, MM-250.

European nomenclature codes declared: Q0210030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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 GTIN17
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. MelaMedic ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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